Medical device for sensing and or stimulating tissue

ABSTRACT

Devices, methods and systems for transmitting signals through a device located in a blood vessel of an animal, for stimulating and/or sensing activity of media proximal to the device, wherein the media includes tissue and/or fluid.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/540,997 filed Aug. 3, 2017 and to U.S. Provisional Application No.62/545,875 filed Aug. 15, 2017, each of which is incorporated herein byreference in its entirety for all purposes.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to a medical device for implantation intoa blood vessel of an animal.

BACKGROUND OF THE INVENTION

Any discussion of document, devices, acts or knowledge in thisspecification is included to explain the context of the invention. Itshould not be taken as an admission that any of the material forms apart of the prior art base or the common general knowledge in therelevant art in Australia or elsewhere on or before the priority date ofthe disclosure and broad consistory statements herein.

In the United States alone, nearly two million people suffer fromvarious neuromuscular disorders where control of limbs is severelyimpaired. In many of these patients, however, the portion of the brainresponsible for movement remains intact, and it is disease and trauma tothe spinal cord, nerves and muscles that limit mobility, function andindependence. For these people, the ability to restore lost control ateven a rudimentary level could lead to a greatly improved quality oflife.

At present, there are two primary options for restoring function. Oneoption is to increase the capabilities of the remaining pathways,substituting paralyzed or amputated muscles with those under voluntarycontrol. While this method has been highly successful for amputees byre-innervating forearm nerves into abdominal muscles which control abionic arm, the restored function greatly depends on the site of damageor condition, with people paralyzed by brainstem or high cervicalinjuries only able to achieve minor functional improvement. A secondoption is to provide the brain with a new communication and controlchannel to convey messages to the external world. Currently, these braincontrolled interfaces (BCIs) measure electroencephalographic or otherelectrophysiological activity via surgically implanted epidural,subdural, and intracortical electrodes. While cortical measurementsperformed with electrodes placed on the scalp enable non-invasiveneuronal measurements, they require daily application and are prone tonoise and movement related artefacts. Penetrating and non-penetratingintracranial electrodes, implanted after a craniotomy directly onto thesurface of a cortical area, have much better signal to noise ratios(relative to scalp electrodes) and have been shown to enable rudimentaryprosthetic hand operation. These methods, however, require invasivesurgery and carry a relatively high risk of complication, which caninvolve infections and bleeding. Furthermore, craniotomies are limitedin access to the central nervous system, with many motor and sensorycortex areas hidden and inaccessible within cortical folds. Theseapproaches are restricted in position and cannot be relocated onceimplanted and are subject to signal deterioration due to glial scarformation surrounding penetrating electrodes.

Thus, there remains a need to record and stimulate from cortical tissuein a method which is minimally invasive whilst also ensuring longevityand efficacy of recorded and induced signals.

By using blood vessels as a conduit to the brain, the risks associatedwith craniotomies, and the invasive creation of a burr hole in the skullof the patient is removed whilst also removing current noise andmovement related artefacts observed with non-invasive scalp electrodes.Despite the minimally invasive benefits provided by these types ofprocedures, it is preferable that thrombus formation caused by theblockage of blood flow through a vessel is prevented. It is alsopreferable that the electrical energy delivered to the electrodes be asefficient as possible, which will reduce the burden placed on theelectrical circuitry. Optimization of wireless telemetry aimed to sendpower and data directly through the body to the implanted device, willenhance device functionality and negate the risk of infection causedthrough lead wires creating a direct passage between the vessel and theexternal environment. The ability to implant coils inside blood vesselswill similarly reduce surgical risks associated with perforatedvasculature.

Thus, there remains a need to provide improved intravascular electrodes,telemetry circuitry and implantation positions that are capable of moreefficiently transmitting and receiving electrical energy between vesselsand external circuitry, while minimizing the occlusion of blood flow.

It is generally desirable to overcome or ameliorate one or more of theabove mentioned difficulties, or at least provide a useful alternative.

SUMMARY OF THE INVENTION

According to the present invention, there is provided a medical devicefor implantation into a blood vessel of an animal, including: (a) astent movable between a collapsed condition of use for insertion intosaid vessel and an expanded condition of use for resiliently bearingagainst a wall of said vessel; (b) one or more electrodes coupled to thestent for stimulating and/or sensing activity of media proximal to thedevice, wherein the media includes tissue and/or fluid. The term stentis meant to include any support structure that maintains, carries,supports or incorporates the one or more electrodes within the tissueand/or fluid. The term stent can include conventionally designed medicalstents, alternatively, the term stent can include any mechanicalframework or scaffolding that positions electrode elements within a bodylumen, such as a vessel, and facilitates electrical coupling of theelectrode element(s) to a lead or other conductive structure. In certainvariations, portions of the support structure itself can function aselectrodes.

According to the present invention, there is also provided a method ofrecording of neural information or stimulation of neurons from thesuperior sagittal sinus or branching cortical veins of a patient usingthe above described device, including the steps of: (a) implanting thedevice in either the superior sagittal sinus or branching corticalveins; (b) receiving activity; and (c) generating data representing saidactivity; and (d) transmitting said data to a control unit.

According to the present invention, there is also provided a method offor stimulation and recording neural information or stimulation ofneurons from the visual cortex of a patient using the above-describeddevice, including the steps of: (a) implanting the device in a vessel inthe visual cortex of the patient; and (b) recording neural informationassociated with the vessel or stimulating neurons in accordance withreceived stimulation data.

According to the present invention, there is also provided a system forcontrolling use of apparatus coupled to an animal or human, including:(a) the above-described device, said device being adapted for placementwithin a vessel of an animal or human to stimulate and/or sense theactivity of media proximal to the device; (b) a control unit adapted forcommunication with the device; (c) apparatus coupleable to the animal orhuman, said apparatus adapted for in communication with the controlunit, wherein the control unit is adapted to perform the steps of: (i)receiving data from the device representing activity of media proximalto the device; (ii)generating control signals for the apparatus; and(iii) sending said control signals to said apparatus.

According to the present invention, there is also provided a controlunit for controlling operation of apparatus coupled to an animal or ahuman, said control unit being adapted to perform the steps of: (a)receiving data from the above-described device, said data representingactivity of media proximal to a vessel within which the device isplaced; (b) generating control signals for controlling operation of theapparatus; and (c) sending said control signals to the apparatus.

The present disclosure further includes a medical device for use withina tubular body having a lumen, the medical device comprising: a framestructure forming a plurality of struts, where the frame structure ismoveable between a reduce profile and an expanded profile in which adiameter of the frame structure increases; where at least one of theplurality of struts forming the frame structure comprises anelectrically conductive material on a support material, the electricallyconductive material extending along at least a portion of the strut andbeing covered with a non-conductive material; at least one electrodeformed by an opening in the non-conductive material on the portion ofthe strut; and a lead located at an end of the frame structure andconfigured to be in electrical communication with the electricallyconductive portion, the lead extending from the frame structure.

The medical device can further include a connector block configuredtoelectrically couple the medical device to an external device, where thelead extends from the frame structure to the connector block.

In another variation, the present disclosure includes a method ofrecording of neural information or stimulation of neurons a patient themethod comprising: receiving a signal representative of neural activityfrom a device positioned in a vessel of the patient; generating datarepresenting said activity using the signal; and transmitting said datato a control unit; generating a control signal from the control unit;and transmitting the control signal to an apparatus coupled to thepatient.

The present disclosure also includes a system for controlling anapparatus coupled to an animal or human. In one example, the systemcomprises a device adapted for placement within a vessel of the animalor human to stimulate and/or sense the activity of media proximal to thedevice; a control unit adapted for communication with the device,wherein the control unit is adapted to: (i) receive data from the devicerepresenting activity of media proximal to the device; (ii) generate acontrol signal; and (iii) transmit the control signal to said apparatus.

The system can include an apparatus selected from or more of thefollowing: an exoskeleton; a prosthetic limb; a wheelchair; a computer;and/or an electrical or electro-mechanical device.

BRIEF DESCRIPTION OF THE DRAWINGS

Variations of the present invention are hereafter described, by way ofnon-limiting example only, with reference to the accompanying drawing.Like reference numerals in the drawings indicate identical orfunctionally similar features/elements throughout. All dimensions shownin the drawings are exemplary.

FIG. 1 is a diagrammatic illustration of a system for controlling use ofapparatus coupled to an animal or a human.

FIG. 2A is a diagrammatic illustration showing parts of the system shownin FIG. 1.

FIG. 2B is a diagrammatic illustration showing of an additionalvariation of the system comprising two or more stents.

FIG. 3 a diagrammatic illustration showing parts of the system shown inFIG. 1.

FIG. 4 is a diagrammatic illustration of a control unit of the systemshown in FIG. 1.

FIG. 5A is a diagrammatic illustration of a medical device of the systemshown in FIG. 1.

FIG. 5B is a cross-section view through the line A-A of the device shownin FIG. 5a .

FIG. 5C is a schematic diagram of a wireless chip.

FIG. 5D is a diagrammatic illustration of a medical device of the systemshown in FIG. 1.

FIG. 6 is a diagrammatic illustration of a medical device located in avessel.

FIGS. 7A to 7E are diagrammatic illustrations of medical device of thesystem shown in FIG. 1.

FIG. 8A is a diagrammatic illustration showing electrode mountingplatforms of a medical device of the system shown in FIG. 1.

FIG. 8B is a diagrammatic illustration showing placements of a medicaldevice of the system shown in FIG. 1.

FIG. 9 shows diagrammatic illustrations of different electrodeconfigurations.

FIG. 10 shows diagrammatic illustrations of different electrodeconfigurations.

FIG. 11 is a diagrammatic illustration of a medical device of the systemshown in FIG. 1.

FIG. 12 shows diagrammatic illustrations of different electrodeconfigurations.

FIG. 13a is a diagrammatic illustration showing wire attachments to anelectrode.

FIG. 13b is a diagrammatic illustration showing electrode lead wireswrapped around a shaft and covered in insulation forming a wire bundleor cable.

FIGS. 13C and 13D illustrate variations of leads coupled to a deviceand, which are configured for repositioning of the lead or device.

FIGS. 14 to 20 are diagrammatic illustrations showing differentembodiments of the stent.

FIGS. 21a to 21c are diagrammatic illustrations showing deployment ofdifferent embodiments of the device.

FIGS. 21d and 21e show additional information regarding a helical lead114.

FIGS. 22 to 24 are diagrammatic illustrations of a control unit of thesystem shown in FIG. 1.

FIGS. 25 and 26 are diagrammatic illustrations showing different stagesof deployment of the device.

FIGS. 27 and 28 are diagrammatic illustrations of control units havingground electrodes attached thereto.

FIG. 29 is a diagrammatic illustration showing multiple vessels withmultiple devices.

FIG. 30 is a diagrammatic illustration showing a single vessel withmultiple devices.

FIG. 31 is a diagrammatic illustration of a wireless electrode system.

FIG. 32 is a diagrammatic illustration of the system being used torecord neural information or stimulation of neurons from the superiorsagittal sinus (SSS) or branching cortical veins of a patient using thedevice.

FIG. 33 shows an image reconstruction of a human brain (eyes facingleft) demonstrating superior sagittal sinus and branching cortical veinsnear the motor cortex (red) and sensory cortex (yellow).

FIG. 34 is a diagrammatic illustration showing a method for stimulationand recording neural information or stimulation of neurons from thevisual cortex of a patient using the device.

FIG. 35 is a diagrammatic illustration showing vessels and muscles in ahuman arm;

FIG. 36 is an illustration of a human hand showing possible implantlocation to enable neural stimulation or measurement.

FIG. 37 is a photo of a C-shaped ground electrode.

FIGS. 38A-38D illustrate examples of stents or scaffoldings having aplurality of electrodes disposed about the stent body.

FIGS. 39A-39C illustrate an example of integrated or embeddedelectrodes.

FIGS. 40A-40B show an example of a stent structure fabricated withdimensional variation to impart specific characteristics to the stent.

FIGS. 41A-41E illustrate a variation of a connector.

FIG. 42 illustrates a variation of a stent electrically coupled to acontrol panel and a connector.

FIGS. 43A-43G illustrate various views of a variation of a connectionpanel.

FIGS. 44A-44D illustrate a variation of an overlay.

FIGS. 45A and 45B illustrate a variation of an overlay.

FIGS. 46A-46F illustrate variations of stents having various electrodeconfigurations.

FIGS. 47A-47F illustrate variations of stents having various electrodeconfigurations.

FIGS. 48A-48D illustrate a variation of a stent.

FIGS. 49A-49C illustrate a variation of a stent.

FIGS. 50A-50C illustrate a variation of a stent.

FIGS. 51A and 51B illustrate a variation of a stent.

FIGS. 52A-52C illustrate a variation of a stent.

FIGS. 53A-53D illustrate a variation of a stent.

FIGS. 54A and 54B illustrate a variation of a stent.

FIGS. 55A and 55B illustrate a variation of a stent.

FIGS. 56A-56D illustrate variations of stents having various electrodeconfigurations.

FIG. 57 illustrates a variation of a stent lattice structure.

FIGS. 58A-58D illustrate a variation of a stent.

FIGS. 59A-59C illustrate a telemetry unit lead having a snake and rungconfiguration.

FIGS. 60A-60D illustrate a variation of a system having a stent incommunication with an external apparatus.

FIGS. 61A-61B illustrate cross sectional views of stent designs withopen cross sections as well as cross sections with a first portion ofthe stent having a first radius and a second portion of the stent havinga second radius.

FIGS. 62A-62B illustrate an improved electrode design with filletededges that gradually taper to the strut.

FIG. 63 illustrates a variation of a stent device with a stent shaftthat has grooves or pockets to assist in joining the shaft to a lead.

FIG. 64 illustrates a planar view of a variation of a stent device wherethe electrodes are specifically designed to limit the number of tracksper strut.

FIG. 65 illustrates a variation of an implantable telemetry unit coupledto a connector via an extension lead arranged in a serpentine fashion.

FIG. 66 illustrates a variation of an algorithm for processing neuralsignals from two or more neural areas.

FIG. 67 illustrates a variation of an algorithm for processing neuralsignals from two or more neural areas.

FIG. 68 illustrates a variation of an adaptive control algorithm.

FIGS. 69A-69E illustrate schematic variations of stent devicesdelivering stimulation to a target location.

FIGS. 70A-70H illustrate schematic variations of stent devices implantedin the brain in various locations delivering various types ofstimulation to various target locations.

FIGS. 70I(a)-70I(g) illustrate schematic variations of stent devicesimplanted in vessels delivering various types of stimulation to varioustarget locations.

FIGS. 71A and 71B illustrate variations of stimulation heat maps.

DETAILED DESCRIPTION

The system 10 shown in FIGS. 1 to 4 includes: 1) a medical device 100designed for placement within a vessel 103 of an animal or human 110 tostimulate and/or sense the activity of media (tissue and fluids)proximal (adjacent or touching) to the device 100, whether this belocated inside or outside the vessel 103; 2) a control unit 12 (alsoreferred to as a connector block and telemetry system) adapted forcommunication with the device; 3) a communication conduit 14 forfacilitating communications between the device 100 and the control unit12; and 4) apparatus 16 coupleable to the animal or human 110, theapparatus 16 adapted for communication with the control unit.

The control unit 12 can be adapted to perform the steps of: (a)receiving data from the device 100 representing activity of mediaproximal to the device 100; (b) generating control signals for theapparatus 16; and (c) sending the control signals to the apparatus 16.In some variations, the system includes connector block (illustrated byelement 12) that functions as connector and acts as an extension of thecommunication conduit. In variations of the system, the controlunit/connector block: is hermetically sealed and insulates the leadsfrom the device to the control unit; can be inserted using zero-contactforce attachments or attachments that do not require excessive force toinsert (i.e., using balseal spring contacts); has a portion of the leadthat is made from a stiffer silicone or similar material for handlingand insertion into the connector. Variations of the device can includemarkers to identify portions of the leads that are stiffer (and can behandled) to distinguish from leads that cannot be handled. Such markerscan include line-style markers, different colours or other indicators toclearly identify the regions. Variations of the connector block can havea fitting (e.g., clasp) such that multiple connectors can be inserted(i.e., two contact connectors (with 8 contacts each) for a 16 electrodeStentrode lead). The fitting can ensure securing of the contacts,alignment and prevention of water ingress

When the medical device 100 is inserted adjacent to the motor cortex inthe manner shown in FIGS. 2A, 2B, and 3, the system 10 can be used, forexample, to control operation of an exoskeleton, and/or an artificiallimb in the manner shown in FIG. 1.

This device 100 is implanted into blood vessels 103, from which, it willutilise electrodes mounted on a self-expanding member 101 to record orstimulate neighbouring tissue. Information is to be passed from or tothe electrodes through the communication conduit 14, inside of the bloodvessel 103, to a telemetry system 12 that, in turn, passes information(using wires or wirelessly) to or from an external apparatus 16, whichincludes (but is not limited to) one or more of the following:

(a) an exoskeleton; (b) wheelchair; (c) computer; and/or (d) otherelectrical or electro-mechanical device.

As such, in one specific application, the implanted medical device 100has the capability to enable a paralysed patient 110 to use theirthoughts directly to command and control a gait aid such as anexoskeleton or robotic legs 16.

Other applications for the implantable medical device 100 include (butare not limited to): (a) detection and prevention of seizures; (b)detection and prevention of involuntary muscular or neural control (forexample to alleviate symptoms associated with: (i) multiple sclerosis;(ii) muscular dystrophy; (iii) cerebral palsy; (iv) paralysis and (v)Parkinsons'; (c) detection and therapeutic alleviation of neurologicalconditions, such as: (i) post-traumatic stress disorder; (ii) obsessivecompulsive disorder; (iii) depression; and (iv) obesity; (d) directbrain control of computers and equipment, such as: (i) vehicles; (ii)wheelchairs; (iii) gait aids; robotic limbs; (e) direct input forsensory stimulation for: (i) blindness (connection to a camera); (ii)deafness (connection to microphone); (iiii) proprioception (connectionto touch-sensitive robotic and computer systems); (f) internalassessment of personal health and wellbeing: (i) heart rate; (ii)respiration rate; (iii) temperature; (iv) environmental conditions; (v)blood sugar levels; and (vi) other biochemical and neurological markers;(g) internal communication (telepathy) between implanted groups ofpeople utilising the device for information transmission, auditory,visual and proprioceptive feedback (for example, real time communicationof what the implantee sees or hears); and (h) augmentation andoptimisation of musculskeletal control and dexterity (for performanceenhancement or rehabilitation).

FIG. 2B illustrates a two-stent 101 system. For purposes ofillustration, the stents are positioned in a single vessel. However, thestents can be configured such that they can be positioned in separatevessels. The stents 101 can be joined by non-conductive material to forma power receiver and transmitting antenna. Alternatively, the stents canbe coupled by one or more wires or conductive elements. Moreover, thesystem can include active electronics between the stents 101.

The devices described herein can be positioned in any number of areas ofbrain structures depending upon the desired outcome. For example, asdiscussed in Teplitzky, Benjamin A., et al. “Computational modeling ofan endovascular approach to deep brain stimulation.” Journal of NeuralEngineering 11.2 (2014): 026011.stents can be positioned as follows:Internal capsule for depression and obsessive compulsive disorder (OCD);thalamus for epilepsy (E), Parkinsons' Disease, essential tremor,Tourette syndrome, consciousness disorder, chronic pain, obsessivecompulsive behavior; fornix for Alzheimer's disease; globus pallidusinternus for dystonia, depression, Tourette syndrome; hippocampus forepilepsy; hypothalamus for obesity, anorexia mentosa; inferior thalamicpduncle for depression and obsessive compulsive disorder; lateralhabenula for depression, obesity, anorexia mentosa; nucleus accumbensfor depression, obsessive compulsive disorder, addiction, obesity,anorexia mentosa; periaqueductal/periventricular for chronic pain;subgenal cingulate white matter for depression; subthalamic nucleus forParkinson's Disease, dystonia, depression, obsessive compulsivedisorder, epilepsy; and ventral capsule for obsessive compulsivedisorder.

1. Medical Device

As shown in FIGS. 5a, 5b, 5d and 6, the medical device 100 generallyincludes: a. a collapsible and expandable stent 101; b. a plurality ofelectrodes 131 coupled to the stent 101; c. electrode lead wires 141electrically coupled to electrodes 131; d. an olive 112 coupled to thestent 101 by an olive wire 114 for preventing perforation of vesselsduring implantation; e. implanted chips; f. contacts 151 couple to thelead wires 141 to enable communication between the device 100 to thecontrol unit 12; and g. a stent shaft 121 is used to deploy the device100.

Electrode lead wires 141 can be electrically connected to at least oneelectrode and will be wound around the stent strut lattice 108 such thatmechanical compression and extension is not interfered with. Electrodewires 141 may be wound around the stent shaft 121, thread through astylet shaft or may form part of the stent shaft directly. Lead wires141 will form connections with electrode contacts 151 on the oppositeend of the stent shaft to the stent, whereby electrical contact aconnector block mechanism 12 enables the connection path with externalequipment 16, which included but is not limited to computers,wheelchairs, exoskeletons, robotic prosthesis, cameras, vehicles andother electrical stimulation, diagnostic and measurement hardware andsoftware.

The term electrode 131 is used in this specification to refer to anyelectrical conductor used to make contact with media in and/or around ablood vessel 103.

A detailed description of the operation of each of these components isset out below.

The Stent

The stent 101 includes a plurality of struts 108 coupled together withstrut crosslinks 109.

In the arrangement shown in FIG. 7a , the device 100 includes nineelectrodes coupled to the stent 101 in a linear pattern. As shown, thestent 101 appears flat. The top of the stent 101 may be directly joinedto the bottom of the stent 101 or will curve around to meet (withoutpermanent attachment) the bottom of the stent 101.

Alternatively, the device 100 includes a stent with any suitable numberof electrodes 131 arranged in any suitable configuration. For example,the electrodes can be configured as follows: the sinusoidal arrangementof electrodes 131 shown in FIG. 7b ; the spiral arrangement ofelectrodes 131 shown in FIG. 7c to enable 360 degree contact of anelectrode to the vessel wall once deployed; the reduced amplitudesinusoidal arrangement of electrodes 131 shown in FIG. 7d for increasedcoverage whilst still ensuring only one stent is at each verticalsegment; and the dense arrangement of electrodes shown in FIG. 7e forincreased coverage. The stent 101 is laser cut or woven in a manner suchthat there is additional material or markers where the electrodes 131are to be placed to assist with attachment of electrodes and uniformityof electrode locations. For example, if a stent 101 was fabricated bylaser cutting material away from a cylindrical tube (original form ofstent), and, for example, electrodes are to be located at 5 mm intervalson the one axis, then electrode mounting platforms 107, 108 can becreated by not cutting these areas from the tube. Similarly, if thestent is made by wire wrapping, then additional material 107, 108 can bewelded or attached to the stent wires providing a platform on which toattach the electrodes. Alternatively, stents can be manufactured usingthin-film technology, whereby material (Nitinol and or platinum and orother materials or combinations of) is deposited in specific locationsto grow or build a stent structure and/or electrode array

Electrodes

As particularly shown in FIGS. 8a , the device 100 includes electrodeplacements 107 coupled to strut crosslinks 109. The placements 107 areused to coupled the electrodes 131 to the stent. An alternativeembodiment of the placements 106 is shown in FIG. 8b . In thisembodiment, the placements are circular.

As shown, the electrodes 131 are located on or at the stent crosslinks109. Locating the electrodes in these positions allows for changes inshape of the stent 101 (i.e expanding and collapsing) withoutsignificantly affecting the integrity of the electrodes. Alternatively,may also be located in between the stent strut crosslinks (notdepicted).

FIG. 9 depicts different electrode geometries which include but are notlimited to: flat discs 161; cylinders or rings 162; half-cylinders orrings 163; spheres, domes or hemispheres 164; hyperbolic parabaloids165; and double electrodes or electrodes whereby they are longer alongone axis 166.

As shown in FIG. 10, the electrodes 131 can include shape memorymaterial and hence the electrodes 131 may be uninsulated sections of thedevice 100. As shown, the electrode 131 inside a patient and the vessel104 is unobstructed. After activation of shape memory, the electrode 131conforms to better fit the vessel wall 103.

To enhance contact and functionality of the device 100, electrodes 131include the attachment of additional material (shape memory alloy orother conducting material) through soldering, welding, chemicaldeposition and other attachment methods to the stent 101 including butnot limited to: directly on or between the stent struts 108; to leadwires 14 passing from the electrodes 131 to wireless telemetry links orcircuitry; and directly to an olive 112 placed on the distal aspect ofthe device 100 to or stent shafts.

To further enhance the device 100 performance, there may be one or moreelectrodes 131 per wire strand 141 and there may be one or more strands141 utilised per device 100. These strands 141 may be grouped to form abundle 144, which may be woven in alternate sinusoidal paths around thestent struts 108 in the manner shown in FIG. 11. Similarly, there may beone or more wires 141 designated to each electrode 131 and hence theremay be one or more electrodes 131 per device 100. Thus, multipleelectrodes 131 may be used simultaneously.

To optimise the ability of the electrodes 131 to stimulate or recordfrom medium (including but not limited to neural tissue, vasculartissue, blood, bone, muscle, cerebrospinal fluid), the electrodes 131may be positioned at pre-determined intervals based on the diameter ofthe target vessel 103 to allow each of the electrodes 131 to be incontact with the vessel 103 in the same orientation (i.e., allelectrodes facing to and in contact with the left vessel wall upondeposition). Electrodes 131 may be mounted such that recordings orstimulation can be directed to all 360 degrees of the vesselsimultaneously. Similarly, to enhance the recording and stimulationparameters of the electrodes 131, the electrode sizes may be varied,with larger electrodes 131 used to assess greater areas of neighbouringmedium with smaller electrodes 131 utilised for localisationspecificity.

Alternatively, the electrodes 131 are made from electrically conductivematerial and attached to one or more stents, which form the device 100and allow for multiple positions. In this embodiment, the electrodes 131are made from common electrically active materials such as platinum,platinum-iridium, nickel-cobalt alloys, or gold, and may be attached bysoldering, welding, chemical deposition and other attachment methods toone or more lead wires 141, which may be directly attached to the shapememory shaft(s). The electrodes 131 can be one or more exposed sectionson the insulated lead wire 141 and the electrode lead wires may bewrapped around one or more shape memory backbones. There may be one ormore electrodes and lead wires wrapped around a single shape memorybackbone, and, where multiple shape memory backbones are used in the onedevice, the backbones may have different initial insertion and secondarydeposition positions. Thus, they may be used for targeting multiplevessels simultaneously.

As shown in FIG. 12, the electrodes 131 can be designed such that theyare carriers of substances 134 and solutions such as therapeutic drugs,including but not limited to anti-thrombogenic, and materials. In thisembodiment, the electrodes 131 are designed to release the drugs, eitherpassively through diffusion or through control by an implantedelectrical clock or manually through electrical stimulation of theelectrodes 131. In this embodiment, the electrodes 131 are made frommaterials that have portions of the electrodes 131 that are notelectrically conductive.

The drug 134 can be released into the vessel 104 upon timed, natural,electrical or otherwise activation, or into the vessel wall 103.

In variations of the device, an insulation layer between the nitinolsubstrate and the electrodes (e.g., platinum, silicone oxide) comprisesa silicone carbide or other insulation material. Alternatively, a layerof silicone carbide can be provided to prevent the degradation anderosion of the silicone oxide layer.

Electrode Wires

The electrode wires 141 are electrically coupled to respectiveelectrodes in the manner shown in FIG. 13a . As shown, the electricalattachment 135 and the back face of the electrode is covered in anon-conductive substance 136.

The lead wires 141 can be wrapped around the stent 101 and along a shaft121.

As shown in FIGS. 5a, 5b and 13b , the electrode lead wires 141 arewrapped around the shaft 121 and covered in insulation 122 forming awire bundle or cable. A sleeve 153 wraps around the wire bundle at thelocation of the contact 151, whereby at least one wire 141 is wrappedaround the sleeve 153 and connected to the contact 151 at a connectionweld point 152. The over-molding 154 ensures a uniform diameter ispresent between contacts.

The sleeve 153 covers the wire bundle 142 with an exposed section ofwire 141 attached 152 to a contact 151.

Distal electrodes and/or markers and/or buffers are also depicted 112attached via a wire 114 to the stent 101. The shaft 121 is attached atthe end of the stent at the attachment/detachment zone 115 and is shownpassing through the sleeve 142 and electrode contacts 151 to exit behindpast the connector securement point 155.

The lead wires 141 shown to be inside the sleeve 142 where they arewrapped around the shaft 121 where they make electrical contact at acontact weld 152 to the electrode contacts 151. An overcoat 154 is shownto ensure uniform diameter of the device between the contacts. The shaft121 may be detached at the detachment zone 115 and removed followingdeployment in a vessel.

As shown in FIG. 13b , lead wires 141 are connected to electrodecontacts 151. Electrode lead wires 141 are initially wrapped around ashaft 121 covered in insulation 122 forming a wire bundle or cable. Asleeve 153 is placed around the wire bundle at the location of thecontact, whereby at least one wire 141 is wrapped around the sleeve andconnected to the contact 151 at a connection weld point 152.Over-molding 154 may be used to ensure a uniform diameter is presentbetween contacts.

As particularly shown in FIG. 5b , the stent shaft 121 is coated in aninsulative layer 122, has a plurality of wires 141 that are insulated143 and grouped in an insulated bundle 142 wrapped around it. A sleeve153 covers the wire bundle 142 with an exposed section of wire 141attached 152 to a contact 141.

The wires 141 are made from electrically conductive materials includingbut not limited to Platinum, Platinum/Tungsten, Stainless Steel,Nitinol, Platinum/Iridium, Nickel-Cobalt Alloys, or other conductive andbiocompatible materials.

The wires 141 are between 10 um and 100 um thick (diameter), strandedcable or monofilament, and connect the electrodes 131 to the contacts151. Alternatively, the wires 141 connect the electrode 131 to wirelesscircuitry retained on the stent or shaft.

The wires 141 are insulated with non-conductive material (i.e., Teflonor polyimide). The wires 141 are wrapped around the stent struts in asinusoidal pattern as shown in FIG. 11. Alternatively, the wires 141 arewrapped in a helical tube or wire bundle or cable, with the wire orbundle between 300 um and 2 mm in diameter (thickness)

The wires 141 are connected to contacts 151 using wire wrapping,conductive epoxy, welding, or other electrically conductive adhesion orconnection means.

FIG. 13C illustrates a variation of a lead 114 coupled to a device 100.In some circumstances, there may be a need retract the device forrepositioning of the device after a sub optimal placement. FIG. 13Cillustrates one variation of a lead 114 having a threaded screw terminal202 that connects the existing lead to an extension lead 206. The leadinclude a female threaded portion 202, which mates with a male portion204 on the extension lead. Placement of the threaded portion on theinterior of the lead reduces the risk that the male portion damages thespring contacts that the device 100 lead fits into after the extensionlead has been removed.

FIG. 13D illustrates an alternative to the screw terminal design shownin FIG. 13C. In this variation, the lead 114 includes a lockingmechanism 208. A variation of the locking mechanism can be based onpressure, where pressure on a selected portion of the lead would enablea latch 208 to open or close. Benefits of this would be to reduce thelikelihood of any twisting of the device during delivery to detach theprematurely. In this variation, the latch 210 on the extension 206 locksinto the lead 114. When an area on the extension is pushed (red arrows)the latch 210 releases from the lead 114 and can be either pushed intothe lead (to attach) or be pulled from the lead (to release). Multiplelatches would be placed around the circumference of the extension 114lead, although one is shown here for purposes of illustration.

Olive

In the embodiment shown in FIG. 5a , the device 100 includes an olive112 mounted at the distal tip to reduce risk of perforation and toimprove device 100 safety during the implantation and deposition phase.In this arrangement, the olive 112 is directly connected to the front ofthe device 100 and act as a buffer, which is the first aspect of thedevice that comes in contact with the deployment catheter or the vesselduring deployment. The olive 112 can additionally be used as aradiopaque distal marker. The olive 112 can be configured and attachedto the stent 101 in many different forms including, but not limited to,the following:

i. Flexible Cord

As shown in FIG. 5a , the olive 112 is placed at a distance from thefront of the stent 101, connecting with the stent 101 via a flexiblecord 114.

ii. Spring Olive

FIG. 14 depicts an olive placed on the distal end of a stent 101 wherebythe olive is comprised of a buffer which may or may not be electricallyactive and function as an electrode 112 connected to the stent 101 by aflexible spring or helically wound wire 111.

iii. Multiple Olives

FIG. 15 depicts a plurality of olives placed on the distal end of astent 101 whereby the olive is comprised of a plurality of buffers whichmay or may not be electrically active and function as an electrode 113.

iv. Short Olive

FIG. 16 depicts an olive placed on the distal end of a stent 101 wherebythe olive is connected directly to the end of the stent which may or maynot be electrically active and function as an electrode 112.

v. Shaped Wire Olive

FIG. 17 depicts an olive placed on the distal end of a stent 101 wherebythe olive is a flexible wire which may or may not be electrically activeand function as an electrode and may or may not be shaped as a shepherdscrook 114.

vi. Wire Olive

FIG. 18 depicts an olive placed on the distal end of a stent 101 wherebythe olive is comprised of a buffer which may or may not be electricallyactive and function as an electrode 112 connected to the stent 101 by aflexible wire 114.

vii. Olive with Detachment Zone

FIG. 19 depicts an olive placed on the distal end of a stent 101 wherebythe olive is comprised of a buffer which may or may not be electricallyactive and function as an electrode 112 connected to the stent 101 by aflexible wire 114. This figure further depicts a shaft 121 that isconnected to the stent 101 via an attachment and/or detachment zone 115.

FIG. 20 further depicts the shaft 121 that is detached from the stent101 via the attachment and/or detachment zone 115.

The flexible wire 114 includes but is not limited to electricallyconductive and electrically insulating wires, springs, helical leads andtubes which may have a buffer at the front. Alternatively, the buffer iselectrically conductive and acts as an electrode, comprising all thefeatures of stent-mounted electrodes.

Implanted Chips

Implanted electrical circuitry (chips) can be used to control thestimulation and measurement of the electrodes 131. The chip can beimplanted in place of an electrode (or elsewhere mounted on the stent),where the chip has the capacity to transmit the signals. The chipincludes circuitry for: (a) signal amplification; (b) signalmultiplexing; and (c) transmission of power and data.

The electrodes 131 are attached to one or more electrical chips (wherebythe chip is defined as the electrical circuitry as well as the substratewhich the chip is built on). Miniaturised chips are mounted on the stent101 in a similar manner and position to the electrodes 131.

Alternatively, these chips may be attached at a distance from the neuralrecording or stimulation site such as the neck or pectoral region, orthe chip may connect directly to external hardware, such as currentsources, recording equipment or prostheses.

The chips can include circuitry for stimulation of neural tissue(current and/or voltage sources, batteries and/or capacitors orcharge/energy storing components and switch matrices, etc) and circuitryfor the recording of neural activity (amplifiers, power sources, switchmatrices, etc) and blood composition (such as pH meters, salts andsaline composition, glucose etc).

Further, chips may have circuitry required for the transmission of powerand data through telemetry coils and self-monitoring hardware such asthermal sensors.

The depiction of the wireless chip 195 shown in FIG. 5c , whereby themicroprocessor 191 is shown as well as other components 193 (e.g.,capacitors, multiplexors, clocks, wireless transmitters, receivers etc).This depiction has two coils that can be used for transmission andreceiving of both power and data, shown as a large coil 192 and a smallcoil 194.

The chip itself may contain a telemetry coil for the transmitting andreceiving power and data and may contain a magnet to enable alignmentwith adjacent chips and telemetry coils or may be attached to shapememory alloys or other materials in which the telemetry coils arecomprised.

The chip can be flexible, and may be pre-curved to the diameter of thevessel to allow for the deposition of the chip within a vessel. Thus,the chip may contain shape memory alloys or polymers to conform the chipto the curvature of the vessel during the deposition phase. The chip mayalso be mounted on a bioabsorbable or biodegradable substrate to allowfor integration within a vessel. Multiple chips may be usedsimultaneously.

f. Contacts

As particularly shown in FIGS. 5a and 5b , electrode contacts 151 arerequired to enable connection of the device 100 to external equipment inthe situation where wireless circuitry is not employed. The electrodecontacts 151 can be made from materials similar to those used by theelectrodes and will be of similar diameters. The contacts 151 areelectrically insulated from each other and will be connected to theelectrode lead wires 141 by (but not limited to) conductive epoxy, laseror resistance welding, soldering, crimping and/or wire wrapping.

The contacts 151 are platinum rings or rings of other conductive,biocompatible materials. The contacts can be made from or containmagnetic materials (i.e., Neodinium).

The contacts 151 can be: (a) between 500 um and 2 mm in diameter; (b)between 500 um and 5 mm in length; and (c) between 10 um and 100 um inthickness.

The contacts 151 are shaped as discs, tubes, parabaloids or other shapessimilar to those used for the electrodes 131.

The contacts are placed over non-conducting sleeve (including but notlimited to a silicone tube, heat shrink, polymer coating) to assist withelectrical insulation of other lead wires and electrode and stent wire,and to assist in retaining shape tubular shape whilst allowing someflexibility.

The contacts 151 can have a contact to contact separation of between 100um and 10 mm, for example, between 1.0 mm and 3.0 mm (e.g., 2 mm or 2.46mm). Other contact separation dimensions, more or less, as well as otherranges, narrower or wider, are also appreciated.

The contacts 151 are formed through wire wrapping of the wires 141.

At least one contact 151 can be a dummy connector (including but notlimited to a metal ring, magnetic ring, plastic tube). A dummy connectorin this instance is a connector that is not in electrical contact withan electrode, instead, the purpose is to enable a connection or securingpoint (i.e., through a screw terminal) to the device in a desiredlocation and such that the contacts (connected to electrodes) are notdamaged.

The contacts 151 are separated by a non-conductive sleeve (including butnot limited to a silicone tube, heat shrink, polymer coating) to reduceelectrical noise and prevent contact between superficial lead wires 141.

g. Shaft

As shown in FIG. 21a , to enable deployment, a flexible shaft 121 isconnected to the device 100. In the example shown in FIG. 21a , theshaft 121 is connected at the distal end of the device 100 such that itacts to pull the device 100 from the front.

In the alternate embodiment shown in FIG. 21b , the shaft 121 isattached to the proximal end of the device 100 such that the shaft 121pushes the device 100 from the back of the stent 101. In thisembodiment, medical device 100 includes a plurality of electrodes 131mounted to a stent 101 with electrode lead wires 141 wrapped around thestent 101 and the shaft 121 and covered in a sleeve 142. Distalelectrodes and/or markers and/or buffers are also depicted 113 as is thestent detachment zone 105.

The further embodiment shown in FIG. 21c includes a double tapered stent101 with mounted electrodes 131 and a stent shaft 121 attached to thestent 101 at the stent attachment/detachment zone 105. Anotherattachment/detachment zone 115 at the front of the stent 101 connectsthe stent 101 to the olive wire 114 and a stylet sleeve 124, throughwhich, a removable stylet 123 is placed. Electrode wires 141 are shownas wrapped around the outside of the stylet sleeve 123 or as being fedthrough the centre.

There may be a plurality of wires, with both pushing and pullingabilities. The stent shafts 121 may be implanted permanently or may bedesigned to be detached and removed. In this embodiment, theattachment/detachment zone will be located at the junction of the stentshaft 121 and the stent 101. Detachment methods include, but are notlimited to, electrochemical detachment, mechanical detachment andthermo-electrical detachment.

The stent shaft 121 can be used as a backbone for electrode lead wires141, assisting the stability of the electrode lead wires 141 as theytraverse from the electrodes 131 to the electrode contacts. In thisembodiment, the electrode wires 141 are in a polymer 142, (including butnot limited to shrink wrap, heat shrink, parylene, silicone, Teflon,etc) to provide additional mechanical support, assist in water retentionand to enable coatings to be deposited onto the stent shaft where wiresare present.

The stent shaft 121 may be a stylet that is removed followingimplantation and deposition of the device 100. In this embodiment, thestent shaft 121 may be a cylindrical tube such that the stylet 123 canbe fed through the centre of the tube 121.

The wires 141 can be thread through the middle of a stylet sleeve.

The wires 141 can be wrapped around the stent shaft or stylet sleeve.

In a further embodiment, the electrode wires 141 that connect theelectrodes 131 to the contacts 152 are wrapped in a wire bundle 144 andwrapped around an internal lumen tubing 145 in a helical form such thatthere is an internal lumen 147 whereby a removable stylet 148 can bethread during insertion and removed following deployment. Thisembodiment enabled removability of the stylet 148 and flexibility of thewire bundle 144 that is over coated in an external tubing 146.

FIGS. 21d and 21e show additional information regarding a helical lead114. As depicted, the helical 114 lead includes wire bundle 144 wrappedaround an internal lumen tube 145. Through the internal lumen 147, aremovable stylet 148 can be thread during delivery and removed followingdevice placement

Control Unit

The control unit 12 shown in FIG. 2 is a wireless controller, relayinginformation and power through the skin wirelessly.

The connector block 12 in FIGS. 22, 23, and 24 are passive devices(i.e., no circuitry). Essentially, it functions as an intermediateconnection between the device 100 and external equipment. The device 100is inserted into the connector block 12 whereby the device 100 contactsmake electrical contact with internal contacts contained within theconnector block 12. These internal contacts of the connector block 12then form a thicker wire bundle which passes through the skin (the restof the connector block is implanted) and can be connected to externalequipment.

Essentially, as we are limited in space (the entire device must passthrough a catheter as the catheter needs to be removed over the deviceafter implantation) the connector block enables attachment of largeritems to the thin device 100.

The embodiments shown in FIGS. 22, 23 and 24 are the same, although onlyFIG. 24 shows the wire that goes through the skin.

The control unit 12 shown in FIG. 22 is shaped to receive and makeelectrical connection with the lead 14. The control unit includecontacts rings mounted on the inside. Here, the connector block 12 issecured and ensured water-tight through attachment of silicone and/orsutures at the grooved end.

The wireless system that is implanted on the stent directly isessentially the same (although a miniaturised version) of the wirelesssystem 12 in FIG. 2.

As shown in FIG. 23, the electrode lead 14 is inserted and a siliconegasket is used to make a watertight seal following

FIG. 24 depicts a connector block whereby the electrode lead 14 isthread through the connection opening 172 whereby the contacts connectwith the electrically conductive connectors 175 inside the connectorblock body 173. Separation and electrical insulation and water-tightnessis increased through silicone (or otherwise) separators 174. Contacts175 are welded (or otherwise) to connector block wires 179 that may forma silicone or otherwise 181 encased bundle 181 to terminate at awireless or direct electrical connection port 183.

Method of Using the System

The device 100 is movable between an insertion position shown in FIG. 25and the deposition or scaffolding position shown in FIG. 26.

In the insertion position, the device 100 is contracted and thus thinenough to be threaded through the vasculature pathway from within acatheter from an entry point (i.e., the jugular vein) to a depositionpoint (e.g., the motor cortex).

When arranged in the deposition or scaffolding position, the device 100is in an expanded condition where scaffold electrodes mounted on theoutside of the stent 101 as pressed against the vessel wall. Thisexpanded position anchors the device 100 in its location within thevessel 103. Further, this deposition position is designed such that ithas a minimal effect on blood flow integrity through the vessel 103 inwhich the device 100 is deposited. The scaffolding position may besynonymous to a spring, coil or helical strand, whereby the device 100is in contact with the vessel wall only, reducing the effect on bloodflow. Electrodes 131 may also be mounted on the inside of the stent 101such that information from fluid flowing through the expanded stent 101can be measured. For a stent 101 to be removed or relocated, additionalshafts (other than that used for initial deployment) are required. Theseare explained in the context of this invention, with both single taperedand double tapered designs used.

To enable the device 100 to be arranged in multiple positions, thematerial used is such that multiple states are possible. These materialsinclude, but are not limited to, Nitinol and other shape memory alloysand polymers. Further, to enhance the long term biocompatibility of thedevice 100, the polymers may be bioabsorbable or biodegradable, with atime of degradation similar to the time in which fibrosis occurs overthe device 100. Hence, the electrodes 131 (which preferably are notdesigned to degrade, and may be made from Nitinol, shape memory alloys,conductive polymers, other non-shape memory alloys and inert andbiocompatible metals such as platinum, iridium, stainless steel andgold) will be all that remains of the initial device 100 and will becomeembed inside the blood vessel 103, further enhancing the stability ofthe device 100 at the location of deposition

Device in Blood Vessel (After deployment)

FIG. 6 depicts a medical device 100 in the expanded or deposition orscaffolding position. The device 100 includes a stent 101, distal olivesand/or proximity markers 112, a wire 114 attaching the stent 101 to theolive 112, a plurality of electrodes 131, and an attachment/detachmentzone 115 whereby the shaft is connected to the stent 101 having beendeployed in a blood vessel 104. Stent 101 mounted electrodes 131 are indirect apposition with the vessel wall 131 and are depicted as notinterruptive of blood flow to any vessel (both the vessel the device isdeployed in and other connected vessels). Here, the olive 112 can beused to direct the medical device into the desired vessel 104.

Device in Blood Vessel Pre-Deployment

FIG. 25 depicts a medical device 100 during implantation (surgicaldeployment phase) as it is being thread through vessels 104 inside acatheter 102. The stent 101, electrodes 131, stent detachment zone 105and stent distal markers/electrodes/buffers 113 are shown, as are thevessel walls 103. Here, the catheter 102 is being used to select anddirect the device into the desired vessel 104.

Device In Blood Vessel After Deployment

FIG. 26 depicts a medical device 100 in the expanded or deposition orscaffolding position comprising a stent 101, distal olives and/orproximity markers 113, a plurality of electrodes 131, lead wires 141 anda stent detachment zone 105 being deployed in a blood vessel 104 througha deposition catheter 102. Stent 101 mounted electrodes 131 are indirect apposition with the vessel wall 103 and are depicted as notinterruptive of blood flow to any vessel (both the vessel the device isdeployed in and other connected vessels).

Ground Electrode

The system can include a ground electrode 167, configured in the mannershown in FIG. 27, which is used to assist and improve the quality of therecorded signals or to provide an electrical return path for stimulationapplications. Here the ground electrode may be placed on the connectorblock provided it is implanted. Ground electrode 167 can be directlyattached to the outside of the wireless controller 12.

An alternative embodiment of the ground electrode 167 is shown in FIG.28. Ground electrode 167 on the outside of the controller 12.

The platinum C-shaped ground electrode 167 shown in FIG. 37 is embed insilicone 181 with a red helical lead wire 141 that is attached to astandard electrical terminal 169. Dacron mesh is used to assist securethe electrode and wire to tissue.

FIG. 29 shows a vessel with multiple devices 100 inserted in differentvessels 104 to access different areas.

FIG. 30 shows a single vessel 104 with multiple devices 100 implanted tocover a larger area.

FIG. 31 a wireless electrode system 1000 showing electrodes mounted on astent 101 within a blood vessel 104 overlying the motor cortex in ahuman that are picking up neural information and relaying thisinformation to a wireless transmitter 1002 located on the stent 101.Note the stent 101 has been deployed and the stylet has been removed(i.e., only the stent 101, electrodes, electrode wires and wirelesssystem 1002 remains). The information is wirelessly transmitted throughthe skull to a wireless received 1004 placed on the head, which in turn,decodes and transmits the acquired neural information to a prostheticlimb 16.

As shown in FIG. 32, the device 100 can be used to record neuralinformation or stimulation of neurons from the superior sagittal sinus(SSS) or branching cortical veins of a patient using the device 100,including the steps of: (a) implanting the device in either the superiorsagittal sinus or branching cortical veins; (b) receiving activity; and(c) generating data representing said activity; and (d) transmittingsaid data to a control unit. Stent 101 implanted in SSS over motorcortex acquiring (i.e. receives) signals that are fed through the wireto external equipment 12.

FIG. 33 shows an image reconstruction of a human brain (eyes facingleft) demonstrating superior sagittal sinus and branching cortical veinsnear the motor cortex (red) and sensory cortex (yellow)

FIG. 34 shows a method of for stimulation and recording neuralinformation or stimulation of neurons from the visual cortex of apatient using the device 100, including the steps of: (a) implanting thedevice in a vessel in the visual cortex of the patient; and (b)recording neural information associated with the vessel or stimulatingneurons in accordance with received stimulation data.

As particularly shown in FIG. 35, the device 100 is delivered through avessel 104 deposited in a muscle for direct muscular stimulation orrecording.

The device 100 can be delivered through a vessel adjacent to aperipheral nerve (such as shown in FIG. 35) for stimulation orrecording.

The device is delivered through a vessel adjacent to a sympathetic orparasympathetic nerve for stimulation or ablation

As shown in FIG. 36, one example of a peripheral nerve (the median nervein this example) showing possible implant location to enable neuralstimulation or measurement.

FIG. 38A illustrates another example of a stent or scaffolding 101having a plurality of electrodes 131 disposed about the stent 101 body.For purposes of illustration, the stent 101 is shown without anyconnecting structure that electrically couples the electrodes to leadsor other such structure that allows electrical communication between theelectrodes and control unit as described above. In the illustratedvariation, the electrodes 131 are dispersed about the body of the stent101 and are located at the joining or apex of joining struts 108. Insuch a configuration, where instead of having cells shaped likediamonds, the cells are shaped like a ‘V’. This configuration canenhance the apposition between the electrodes 131 and the tissue orvessel wall.

FIG. 38A also illustrates a variation of a stent 101 that can befabricated where stent structure comprises an integrated conductivelayer that extends through a portion or more of the stent strut 108 andwhere the electrode 131 is formed through an exposed portion of theintegrated conductive layer. Such a stent configuration, as described indetail below, permits a stent 101 electrode 131 assembly, which embedselectrodes and conductive electrode tracks into the stent lattice orstrut itself. Such a construction reduces or eliminates the requirementto use fixation methods (i.e., adhesives, glues, fasteners, welds, etc.)to mount electrodes to the body of the stent. Such a constructionfurther reduces or eliminates the need to further weld or electricallyconnect electrodes to wires. Another benefit is that conventionalwire-connected-electrodes require accommodation of the wires about thestent struts and through the body of the stent.

FIG. 38B illustrates a stent structure 101 with integrated electrodes131, where the stent structure is coupled to a shaft 121 at a distal end146. The shaft, as described herein, can electrically couple theelectrodes 131 to one or more control units (not shown) as describedherein. In one example, the shaft 121 can comprise a guidewire, pushwire other tubular structure that contains wires or conductive membersextending therein and are coupled to the conductive layer of the stentat the distal end 146. Alternatively, FIGS. 38C and 38D shows avariation of stents 101 that can be fabricated such that the shaft 121is part of or integral with the stent structure, where the conductivelayer extends through a portion or all of the stent to the shaft 121.Such a construction further eliminates the need for joining the shaft tothe stent structure at the working end of the stent. Instead, thejoining of the stent structure (forming the shaft) to a discrete shaftcan be moved proximally along the device. Such a construction allows theworking end of the stent and shaft to remain flexible. The stentstructures shown in FIGS. 38C and 38D can also include an optionalreinforced section 62 as discussed above. FIG. 38C further illustrates ahollow shaft 121, which allows insertion of a stylet 123 therethrough toassist in positioning of the device or permits coupling of wires orother conductive members therethrough. Furthermore, the shaft 121 caninclude any number of features 119 that improve flexibility orpushability of the shaft through the vasculature.

The electrical connection of the electrodes 131 to leads extendingthrough the device can be accomplished by the construction of one ormore connection pads (similar in construction to the electrodesdescribed below) where the size of the pads ensures sufficient contactwith the wire/lead, the type of pads ensures robustness and reducestrack fatigue when crimped and attached. The section containing the padscan be compressed into a tube at, for example, distal section 146 toenable insertion of a cable 121.

In certain variations, the connection pads should be able to feedthrough the catheter. Furthermore, the connection pads 132 can includeone or more holes or openings that enable visual confirmation that thepads are aligned with contacts on the lead. These holes/openings alsoenables direct/laser welding or adhesion of the contact leads (insidetube 121) and the contact pads (on the inside of the tube spanningthrough the hole to the outside)

In one example, a coaxial- octofilar cable (i.e. an inner cable with 8wires positioned inside an outer cable having 8 wires) is used toenhance fatigue resistance and to ensure that wires can fit withinconstraints (i.e., can be inserted through a sufficiently smallcatheter, and can have an internal stylet as required).

FIGS. 39A-39C illustrate one example of a stent structure 101constructed with an embedded electrode and conductive path. FIG. 39Aillustrates an example of a stent structure 101 in a planarconfiguration with electrodes 138 in a linear arrangement for purposesof illustration only. Clearly, any configuration of electrodes is withinthe scope of this disclosure. Specifically, in those variations of stentstructures useful for neurological applications, the stent structure cancomprise a diameter that is traditionally greater than existingneurological stents. Such increased diameter can be useful due to thestent structure being permanently implanted and while requiringapposition of electrodes against the vessel/tissue wall. Moreover, insome variations, the length of such stent structures can include lengthsup to and greater than 20 mm to accommodate desired placement along thehuman motor cortex. For example, variations of the device require astent structure that is sufficiently long enough to cover the motorcortex and peripheral cortical areas. Such lengths are not typicallyrequired for existing interventional devices aimed at restoring flow oraddressing aneurysms or other medical conditions. In addition, incertain variations, the electrical path between certain electrodes canbe isolated. In such a case, the electrically conductive material 50 canbe omitted from certain stent struts to form a pattern that allows anelectrode to have an electrical conduction path to a contact pad orother conductive element but the electrical conduction path iselectrically isolated from a second electrode having its own secondelectrically conductive path.

Placement of the electrodes in a specific pattern (e.g., a corkscrewconfiguration or a configuration of three linear (or corkscrew oriented)lines that are oriented 120 degrees from each other) can ensure adeployed electrode orientation that directs electrodes towards thebrain. Once implanted, orientation is not possible surgically (i.e., thedevice will be implanted and will be difficult if not impossible torotate). Therefore, variations of the device will be desirable to havean electrode pattern that will face towards the desired regions of thebrain upon delivery.

Electrode sizing should be of a sufficient size to ensure high qualityrecordings and give large enough charge injection limits (the amount ofcurrent that can be passed through the electrodes during stimulationwithout damaging the electrodes which in turn may damage tissue). Thesize should also be sufficient to allow delivery via a catheter system.

FIGS. 39B and 39C illustrates a cross-sectional view of the stentstructure of FIG. 39A taken along line 39B-39B to further illustrate onevariation of a manufacturing technique of using MEMS (microelectricalmechanical systems) technology to deposit and structure thin filmdevices to fabricate a stent structure with electrodes and a conductivepath embedded into the stent lattice or struts. The spacing of thestruts in FIGS. 39B and 39C are compressed for illustrative purposesonly.

As discussed above, embedding the electrode and conductive path presentsadvantages in the mechanical performance of the device. Furthermore,embedding of electrodes provides the ability to increase the number ofelectrodes mounted on the structure give that the conductive paths(30-50 μm×200-500 nm) can be smaller than traditional electrode wires(50 -100 μm).

Manufacture of thin-film stents can be performed by depositing Nitinolor other superelastic and shape memory materials (or other materials fordeposition of electrodes and contacts (including but not limited togold, platinum, iridium oxide) through magnetron sputtering in aspecific pattern (56) using a sacrificial layer (58) as a preliminarysupport structure. Removal of the support structure (54) enables thethin film to be further structured using UV-lithography and structurescan be designed with thicknesses corresponding with radial forcerequired to secure the electrodes against a vessel wall.

Electrical insulation of electrodes is achieved by RF sputtering anddeposition of a non-conductive layer (52) (e.g., SiO) onto the thin-filmstructure (54). Electrodes and electrode tracks (50) are sputterdeposited onto the non-conductive layer (using conductive andbiomedically acceptable materials including gold, Pt, Ti, NiTi, PtIr),with an additional non-conductive layer deposited over the conductivetrack for further electrical isolation and insulation. As shown,conducting path 50 is left exposed to form the electrode 138 (similarly,a contact pad area can remain exposed). Finally, the sacrificial layer56 and substrate are removed leaving the stent structure 101 as shown inFIG. 39C.

In certain variations where the base structure 54 comprises superelasticand shape-memory materials (i.e. Nitinol), the stent structure 101 canbe annealed in a high vacuum chamber to avoid oxidation during theannealing process. During heat treatment, the amorphous Nitinolstructure 54 crystallizes to obtain superelasticity and can besimultaneously shape set into a cylindrical or other shape as desired.The structure 101 can then be heat treated.

FIG. 40A, which is a partial sectional view of taken along lines 40A-40Aof FIG. 41B, illustrate an additional variation of a stent structure 101fabricated via MEMS technology where one or more stent struts 108 can bedimensionally altered to impart desired structural or other aspects tothe stent structure 101. For example, in the illustrated variation,certain stent struts 108 are dimensionally altered such that the supportmaterial 60 comprises a greater thickness than adjacent stent structures108. However, such dimensional variation is not limited to thickness butcan also include width, shape, etc.

FIG. 40B illustrates the stent structure 101 resulting from thedimensionally altered struts resulting in a sinusoidal section 62 of thestent structure 101 that comprises a greater stiffness (resulting fromthe increased thickness). Such a configuration allowing the stent deviceto be pushed through a catheter rather than conventional requirements tobe unsheathed (where the sheath is pulled back over the stent).Conventional stents are made from a thin lattice of Nitinol diamonds orcells. This sinusoidal section 62 can function like a backbone and givesforward pushing strength to the device without restrictingsuper-elasticity and the ability for the stent to compress and expand.Clearly, any number of variations of dimensionally altered strutsections are within the scope of this disclosure.

FIGS. 41A-41E illustrate various aspects of a variation of a connector200 that can be in electrical communication with a stent (e.g., stent101) and a receptacle (e.g., control unit 12). For purposes ofillustration, the connector 200 is shown isolated from the stent 101 andthe receptacle 12. As described above, the connector 200 can allowelectrical communication between the electrodes and the control unit.

FIG. 41A illustrates that the connector 200 can have a dual-octofilercable (also referred to as a coaxial-octofiler cable). Thedual-octofiler cable can have a first coil 201 (e.g., inner coil) and asecond coil 202 (e.g., outer coil). The first and second coils 201, 202can each have 8 wires 141. Other numbers of wires, more or less, arealso appreciated. The first coil 201 can be positioned within a lumen ofthe second coil 202. The first coil can be positioned within a lumen ofan internal tubing 145. The first and/or second coils 201, 202 can bepositioned within a lumen of an external tubing 146. The first andsecond coils 201, 202 can be wound coils. The first and second coils201, 202 can be helical coils. For example, the first coil 201 can bewrapped along an inner surface of the internal tube 145 and the secondcoil 202 can be wrapped along an outer surface of the internal tube 145.As described above, the dual-octofiler configuration can be used toenhance fatigue resistance and to ensure that wires can fit withinconstraints (i.e., can be inserted through a sufficiently smallcatheter, and can have an internal stylet as required).

An insulator (e.g., polyurethane) can cover one or more wires 141 of thecoils 201, 202 (i.e., the wires 141 can be insulated). An insulator(e.g., polyurethane) can be positioned between the first and secondcoils 201, 202. For example, the internal tube 145 can be an insulatorthat can be positioned between the first and second coils 201, 202. Aninsulator (e.g., polyurethane) can cover the first and/or second coils201, 202 (i.e., the first and second coils 201, 202 can be insulated).

The first coil 201 can have a length that is less than, greater than, orequal to the length of the second coil 202. For example, the first coil201 can be longer than the second coil 202. The first coil 201 can havea diameter that is less than, greater than, or equal to the diameter ofthe second coil 202. The first and/or second coils 201, 202 can eachhave one or more diameters. For example, the first coil 201 can have twodiameters and the second coil 202 can have one diameter. The first coil201 can have a first diameter and a second diameter. The first diametercan correspond to where the first coil 201 is positioned within thesecond coil 202 and the second diameter can correspond to where thefirst coil 201 is not positioned within the second coil 202 (e.g., whereit extends past the first coil 201). Other arrangements are alsoappreciated.

Although not shown in FIG. 41A, the external shaft 146 can comprisecontacts 151 and separators 174 (e.g., insulators). The separators 174can be positioned next to contacts 151 to keep the contacts 151electrically insulated from one another. The wires 141 of the first andsecond coils 201, 202 can be electrically connected to the contacts 151.For example, the 8 wires 141 of the first coil 201 and the 8 wires 141of the second coil 202 can each be electrically coupled to acorresponding contact 151.

The first coil 201 can allow a stylet 148 (not shown) to travel throughit. For example, the first coil 201 can define a lumen that allows astylet 148 to pass through the first coil 201. The inner surface of thefirst coil 201 can be insulated and/or not insulated.

The first and second coils 201, 202 can have a wound section and anunwound section. For example, the first and second coils 201, 202 cantransition from a wound section to an unwound section. The wound sectionhave helical wires and the unwound section can have straight, curved(e.g., have one or more bends), and/or angled (e.g., have one or morebends) wires. The wound and unwound sections can be flexible and/orrigid. For example, the wound section can be flexible and the unwoundsection can be rigid.

The first and second coils 201, 202 can have a helical section and anon-helical section. For example, the first and second coils 201, 202can transition from a helical section (e.g., where the wires 141 definea helix) to a non-helical section (e.g., where the wires 141 do notdefine a helix). For example, the wires 141 in the non-helical sectioncan be unwound to no longer form a coil. The wires 141 in thenon-helical section can be straight, curved (e.g., have one or morebends), and/or angled (e.g., have one or more bends). The helical andnon-helical sections can be flexible and/or rigid. For example, thehelical section can be flexible and the non-helical section can berigid.

The first and second coils 201, 202 can each have one or more channels.For example, the first and second coils 201, 202 can each have 8channels. Other numbers of channels, more or less, are also appreciated(e.g., 9 to 16 channels, or more). Other numbers of coils are alsoappreciated, for example, 3 or more coils. For example, it will beappreciated that another coil can be positioned within the lumen of thefirst coil 201 and/or on the outside of the second coil 202.

FIG. 41B illustrates a cross-sectional view of the connector 200 shownin FIG. 41A taken along the line 41A-41A to further illustrate the firstand second coils 201, 202 of the dual-octofiler coil configuration. FIG.41B also illustrates that the first coil 201 can step-up 203 in diameterto match or otherwise approach the diameter of the second coil 202. Thestep-up 203 can occur somewhere along the length of the first coil 201and somewhere along the length of the second coil 202. For example, thefirst coil 201 can step-up 203 at about the midpoint of the first coil201 and at an end of the second coil 202 (e.g., a terminal end). Thefirst coil 201 can step-up 203 to contact the leads 151, for example, sothat uniformly sized leads 151 can be used. The first coil 201 canstep-up 203 to attach to the leads 151. However, it will be appreciatedthat the leads 151 can have one or more sizes. With or without thestep-up 203, the receptacle 12 can have a step in it so that thecontacts 175 of the receptacle 12 can make contact with the contacts 151in contact with the first coil 201. The various components of the dualoctofilar cable can have the various dimensions shown (in inches).

FIG. 41C illustrates another perspective view of the connector 200 ofFIG. 41A, but with the outer shaft 146 made transparent for purposes ofillustration. As described above, the second coil 202 can be wrappedaround the inner shaft 145 and the first coil 201 can have a step-up203. FIG. 41C illustrates that the 8 wires 141 of the first and secondcoils 201, 202 can have terminal ends 207. As shown, the wires 141 ofthe second coil 202 can terminate first, followed by the wires 141 ofthe first coil 201. The terminal ends 207 of the second coil 202 canattach to the first 8 leads 151 of the connector 200 and the terminalends 207 of the first coil 201 can attach to the second 8 leads 151 ofthe connector 200. The first 8 leads 151 can be closer to a first end210 a of the connector 200 and the second 8 leads 151 can be closer to asecond end 210 b of the connector 200. Any connection sequence isappreciated, including, for example, connecting from proximal to distal(e.g., from first end 210 a to second end 210 b) as shown, from distalto proximal, alternating, etc. The terminal ends 207 can be electricallycoupled to contacts 151 as described above (e.g., by welding). Theterminal ends 207 can be exposed to the contacts 151 to establish anelectrical path between the leads 151 and the electrodes 131, 138.

FIG. 41C also illustrates that the helix angle of the second coil 202can change, for example, at position 204. The helix angle of the secondcoil 202 can increase or decrease. For example, the helix angle canincrease near where the second coil 202 makes contact with the firstcontact 151. Other numbers of changes in the helix angle of the secondcoil 202, more or less, are also appreciated (e.g., including zerochange to two or more changes).

FIG. 41D illustrates another perspective view of the connector 200 ofFIG. 41A, but with the inner and outer shafts 145, 146 made transparentfor purposes of illustration. FIG. 41D illustrates that the helix angleof the first coil 201 can change, for example, at position 205. Thehelix angle of the first coil 201 can increase or decrease. For example,the helix angle can increase near where the last terminal end 207 of thesecond coil 202 makes electrical contact with an eighth contact 151.Other numbers of changes in the helix angle of the first coil 16, moreor less, are also appreciated (e.g., including zero change to two ormore changes).

FIG. 41E illustrates the connector 200 of FIG. 41A with the leads 151and separators 174 shown. The leads and separators 151, 174 can bepositioned relative to one another in an alternating pattern. Asdescribed above, each wire 141 of the first and second coils 201, 202terminate on a contact 151. The wires/filars 141 are exposed andattached (e.g., welded) to the inner surface (e.g., inner diameter) ofthe leads 151.

The connector 200 can be inserted into and/or attached to a receptacle12 as described above. The connector 200 can be plugged into areceptacle 12 as described above. FIG. 41E illustrates that theconnector 200 can have a retention member 206 (e.g., retention ring 206)that can engage with and/or attach to the receptacle 12. To accomplishthis, the retention member 206 can form a ring or a ring-like structure,although other shapes are also appreciated. For example, the receptacle12 can be screwed onto the retention member 206. The retention member206 can have internal and/or external screw threads. For example, theretention member 206 can comprise a set screw. The retention member 206can have a longer longitudinal dimension than one of the contacts 151.

The retention member 206 can be rigid to provide the connector 200 withstructural support before, during and after implantation. Other parts ofthe connector 200 can be flexible so that the connector 200 can navigateor otherwise conform to the tortuosity of a blood vessel. For example,the portion of the connector 200 that is between the retention member206 and the second end 210 b of the connector 200 can be flexible (thisportion is also referred to here as the lead body). The lead body of theconnector 200 can flex 90 degrees around a 6 mm radius. Other angles andradii, more or less, are also appreciated. The connector 200 (e.g., thesecond end 210 b of the connector 200) can flex 45 degrees around aradius of 0.5 mm. Other angles and radii, more or less, are alsoappreciated. The connector 200 can be looped around a 1 cm radius. Otherloop radii, more or less, are also appreciated.

In the lead body portion of the connector 200, the coils 201, 202 can beallowed to float such that they are not embedded in insulation. Thecoils 201, 202 can be embedded in insulation within the retention member206 and/or within the lead body portion. The separators 174 can beover-molded to ensure a uniform diameter is present between contacts.

FIG. 41E illustrates that the lead wires 141 can extend beyond the firstend 210 a of the connector 200. The lead wires 141 that extend beyondthe first end 210 a of the connector 200 can be unwound (e.g., uncoiled)such that each wire 141 can individually connect to a connection panel(e.g., connection panel 220 described below), or otherwise connect tothe connection panel in one or more bundles 144 of wires 141. Forexample, the lead wires 141 can transition from coiled configurationsinto 16 tailed ends that can connect to the connection panel. The 16tailed ends can be straight and/or curved. The connection panel canelectrically couple the connector 200 to the electrodes 131, 138. Forexample, FIG. 41E illustrates that the first and second coils 201, 202can be unwound and grouped into three bundles 144 of lead wires 141.Other numbers of bundles, more or less, are also appreciated. Wires fromthe first and second coil 201, 202 can be bundled with first coil 201wires 141 and/or with second coil 202 wires 141. It is appreciated thatindividual wires 141 and one or more bundles of wires 144 can extendfrom the connector 200 to connect with the connection panel. The wires141 can unwind/uncoil over some dimension within the retention member206 and/or over some dimension within the rest of the connector 200. Thewires 141 and/or bundles 144 that extend from the connector toward thestent 101 can be rigid and/or flexible.

The wires 141 can be directly connected to the stent 101, for example,with laser welding. For example, the wires 141 can be directly connectedto pads on the stent 101. The wires 141 can be indirectly connected tothe stent 101, for example, with wire bonding. For example, the wires141 can be indirectly connected to pads on the stent 101 via connectionto intermediate pads. The pads on the stent 101 can be wire bonded tothe intermediate pads, for example, with jumper wires.

FIG. 42 illustrates that the connector 200 of FIGS. 41A-41E can beelectrically coupled to the electrodes 131, 138 of the stent 101 via aconnection panel 220. FIG. 42 illustrates that the wires 141 of theconnector 200 can be indirectly connected to the stent 101 via theconnection panel 220. The connection panel 220 can have a first panel(e.g., an overlay) and a second panel (e.g., a stentrode panel)electrically coupled together. The first and second panels can each haveone or more connection pads. The pads can be made of platinum or otherconductive materials. The wires 141 of the connector 200 can beelectrically connected to one or more pads of the first panel and theconductive paths (also referred to as electrode tracks) of the stent101can be electrically connected to one or more pads of the secondpanel. One or more jumpers can be used to electrically connect the firstpanel to the second panel. For example, one or more jumpers can be usedto electrically connect the first panel pads to the second panel pads.The one or more jumpers can electrically connect the pads of the firstpanel to the pads of the second panel, thereby electrically connectingthe leads 151 of the connector 200 to the electrodes 131, 138 of thestent 101. Attaching the wires/filars 141 to the first panel canadvantageously provide a more stable and reliable connection thandirectly attaching the wires/filars 141 to the stentrode pads (e.g., tothe second panel pads). The first and/or second panels can be attachedto the connector 200, for example, by welding or other attachmentmethod. The first and second panels can each have 16 pads. Other numbersof pads, more or less, are also appreciated (e.g., 1 pad to 32 or morepads). An insulating material (e.g., epoxy) can cover the connectionpanel 220.

More than one connection panel 220 can be used. For example, twoconnection panels 220 can be used. The use of two connection panels 220can advantageously make connections easier and give more space for wiremanagement relative to the use of only one connection panel 220 sincenot all 16 wires 141 are connected to the same area when two connectionpanels are used. The use of multiple connection panels can help providestructural support to the connection panel region when the stentrode isbeing pushed out of the delivery system. For example, the use ofmultiple connection panels can help distribute the force/axial load thatis applied when the system is pushed through a delivery system (e.g., acatheter). The use of multiple connection panels is also advantageousfrom a processing and fatigue resistance standpoint.

The one or more connection panels 220 can be aligned with a backbone ofthe stent 101. For example, the one or more connection panels 220 can bealigned with struts 108, thicker struts 108, and/or with a reinforcedsection 62.

The transition from the dual coils 201, 202 to the leads 141 extendingtoward the panel 220 can include unwinding/uncoiling the first andsecond coils 201, 202 as described above.

The connector 200 (also referred to as an endovascular implantable lead)can be configured to transmit neural interface sensor data to animplantable telemetry unit (e.g., control unit 12). The dual-octofilercoils 201, 202 can advantageously withstand long term repetitivemovement and trauma due to neck movements, among other movements. Theuse of dual-octofiler coils 201, 202 can advantageously reduce noise dueto muscle artifacts.

The pads on the stent can be connected to the conductors in the leadbody by a variety of methods including but not limited to resistancewelding, laser welding (each involving direct contact between the padson the Stentrode and the lead), and/or wire bonding (connection betweenthe Stentrode and the lead via an intermediate pad).

FIGS. 43A-43F illustrate various views of a variation of a portion of aconnection panel 220. As shown, the connection panel 220 can have afirst panel 222 (e.g., an overlay) attached to a portion of the stent101, for example, a second panel 224. The second panel 224 can be aconnection paddle. The second panel 224 can be integrated with orattached to the stent 101. The second panel 224 can have multiple pads(not shown) and multiple electrode tracks 236. The electrode tracks 236can be electrically connected to the pads of the second panel 224. Thefirst panel 222 can have multiple pads 226 and multiple openings 228(also referred to as windows or holes). The pads can be made of platinumor other conductive materials. The openings 228 can be aligned with orotherwise placed over the pads on the stent 101. The first panel 222 canhave the same number or a different number of pads 226 and openings 228.For example, the first panel 222 can have 16 pads 226 and 16 openings228, although other numbers of pads and openings, more or less, are alsoappreciated (e.g., 1 to 32 or more pads and openings). As anotherexample, the first panel 222 can have more pads 226 than openings 228.As yet another example, the first panel 222 can have fewer pads 226 thanopenings 228. The stent 101 can have the same number or a differentnumber of pads as the number of openings 228 in the first panel 222. Forexample, the stent 101 can have 16 pads and the first panel 222 can have16 openings 228. As another example, the stent 101 can have 16 pads andthe first panel 222 can have fewer than 16 openings 228 (e.g., 4 or 8openings).

FIGS. 43A and 43B illustrate that the windows 228 can have a reducedcross-sectional area relative to the cross-sectional area of the pads226. This can advantageously increase/optimize the operating space onthe first panel 222 for wire management. The pads and windows 226, 228can be arranged in various patterns to increase/optimize the operatingspace on the first panel for wire management. The pattern shown in FIGS.43A and 43B is non-limiting, as any suitable pattern of pads and windows226, 228 is appreciated. FIG. 43G illustrates a variation of the padsand openings 226, 228. The pads 226 can have, for example, a pad firstdimension and a pad second dimension. The pad first dimension can be apad length and the pad second dimension can be a pad width. The padfirst dimension can be greater than, less than or the same as the padsecond dimension. For example, FIG. 43G illustrates that the pad firstdimension can be greater than the pad second dimension. The pad firstdimension can be, for example, about 0.05 mm to about 1.00 mm, less than10.00 mm, including every 0.01 mm increment within these ranges (e.g.,0.50 mm). The pad second dimension can be, for example, about 0.04 mm toabout 1.00 mm, less than 10.00 mm, including every 0.01 mm incrementwithin these ranges (e.g., 0.13 mm). The openings 228 can have, forexample, an opening first dimension and an opening second dimension. Theopening first dimension can be an opening length and the opening seconddimension can be an opening width. The opening first dimension can begreater than, less than or the same as the opening second dimension. Forexample, FIG. 43G illustrates that the opening first dimension can begreater than the opening second dimension. The opening first dimensioncan be, for example, about 0.05 mm to about 1.00 mm, less than 10.00 mm,including every 0.01 mm increment within these ranges (e.g., 0.24 mm).The opening second dimension can be, for example, about 0.04 mm to about1.00 mm, less than 10.00 mm, including every 0.01 mm increment withinthese ranges (e.g., 0.08 mm).

FIGS. 43C and 43D illustrate that wire bonds 230 can be made between thepads on the stent 101 and the pads 226 on the overlay 222. FIG. 43D is amagnified view of the wire bonds 230 of FIG. 43C at section 43D-43D. Oneor multiple wires 232 can pass through each of the windows 228. Forexample, two wires 232 are shown in FIGS. 43C and 43D passing throughtwo different windows 228.

FIGS. 43E and 43F illustrate that the wires 141 can be attached (e.g.,welded) to the pads 226 on the overlay 222. FIG. 43F is a magnified viewof the wires 141 attached to the pads 226 of FIG. 43E at section43E-43E. An insulating material 234 (e.g., epoxy) can cover at least aportion of the wires 141.

FIGS. 44A-44D illustrate a variation of an overlay 222 for wire bondingto a stent 101. The overlay 222 can have the various dimensions shown(in inches). The overlay 222 of FIGS. 44A-44D is similar to the overlay222 of FIGS. 43A-43F except the pattern of the pads and openings 226,228 is different, and the openings 228 are larger. FIG. 44C is amagnified view of one of the pads 226 of FIG. 44A at section 44C-44C.FIG. 44D is a magnified view of the opening 228 of FIG. 44A at section44D-44D. The pads and openings 226, 228 can have the various dimensionsshown (in inches). Wire bond pads can be placed in specific locations toenable all 16 electrode tracks to fit within the 900 μm width withenough separation that unwanted electrical connection is avoided. Theoverlay 222 can have a similar width to enable deployment through a 1 mminternal diameter catheter.

FIGS. 45A and 45D illustrate a variation of an overlay 222 for wirebonding to a stent 101. FIG. 45A illustrates a top view of the overlay222 and FIG. 45B illustrates that the overlay 222 can be placed over theportion of the stent 101 having pads. The pads of the stent can beelectrically connected to the electrodes 131 (not shown) via theelectrode tracks 236. The pads and openings 226, 228 can have thevarious dimensions shown. This design, and similar changes to the padson the stent 101, can advantageously allow for linear attachment of thepads 226 to the wire bonding holes 228, which can make manufacturing theconnection panel 220 easier than, for example, the connection panelassociated with FIGS. 44A-44D.

FIGS. 43A-45D illustrate that the wires 141 can be indirectly connectedto the stent 101, for example, with wire bonding. The wires 141 can beindirectly connected to pads on the stent 101 via connection tointermediate pads 226 on the overlay 222. Such an intermediateconnection method can advantageously allow for thicker/stronger wires141 to be used to connect the lead 200 to the overlay 222. Welds fromthe overlay 222 to the stent 101 can overcome limitations on the stent101 of having a small amount of platinum to weld to. This isadvantageous relative to, for example, laser welding because laserwelding typically requires more material which is melted to form a poolduring welding. With a small amount of material, the melted pool cancause the track material to be sucked up into the pool, causing thetracks to break during manufacture.

FIGS. 46A-46F illustrate variations of stents 101 having variouselectrode 131configurations. Each of these stents 101 can advantageouslyposition electrodes 131 in a manner that, regardless of the manner inwhich the stent 101 is delivered into a vessel, there will always besufficient electrodes 131 pointing to an information rich area of thebrain (e.g., motor cortex, sensory cortex, among others) upon expansionfrom a compressed configuration. For purposes of illustration, thestents 101 are shown without any connecting structure that electricallycouples the electrodes 131 to leads or other such structure that allowselectrical communication between the electrodes 131 and the control unit12 as described above.

As shown, the electrodes 131 can be dispersed about the body of thestents 101at various locations. FIGS. 46A-46F illustrate that the stents101 can have one or more cell sizes and/or shapes (e.g., diamond-shaped,V-shaped, among others). For example, the stents 101 can have cells thatare longer than they are wide (L>W). This can advantageously allow forgreater compression and reduce the force required to retract the stents101 into a delivery instrument (e.g., a stylet or delivery catheter) andreduce the force required to deploy the stents 101from within thedelivery instrument. The stents 101 can have one or more cells that arewider than they are long (W>L). The stents 101 can have some cells thatare longer than they are wide (L>W) and some cells that are wider thanthey are long (W>L). Such cell variations can advantageously accommodatevarious vessel physiologies.

One or more of the electrodes 131 can be attached to, embedded into,and/or otherwise integrated with the stents 101 as described above. Forexample, the stents 101 can have one or more integrated conductivelayers (also referred to as electrode tracks and electrical tracks). Theelectrode tracks can have a thickness from about 200 μm to about 1000μm. Other track thicknesses, more or less, as well as other ranges,narrower or wider, are also appreciated. Electrode tracks with thesethicknesses can advantageously decrease the electrical resistance of theelectrode track and provide more material (at the connection end) forwelding. In FIGS. 46A-46F, the electrode track thickness is thedimension into the page (i.e., not width or length, which can remainconstant to reduce the overall thickness of the Stentrode struts wheremultiple tracks are present, such as the fork 302 on the far left of thefigures). The thickness of the struts 108 (i.e., the material underneaththe insulation layers and electrical tracks) can be from about 50 μm toabout 100 μm, for example, 50 μm, 85 μm, or 100 μm. Other strutthicknesses, more or less, as well as other ranges, narrower or wider,are also appreciated. The strut 108 thickness can increase or decreasegradually and/or in a step-wise manner along the stent 101 (e.g.,gradually increase from 50 μm to 85 μm or step up from 50 μm to 85 μm).Thicker struts can have a larger radial and axial force relative tothinner struts. The thicker struts can therefore advantageously increasethe apposition between the stent 101 and a vessel wall. The thickerstruts can therefore increase the ability of the stent 101 to be pushedforward and deployed from within a delivery instrument (e.g., acatheter). The stents 101 can be thickest near the forks 302 on theproximal end of the stents 101 and can be thinnest at the distal end ofthe stents 101. The stents 101 can become thinner from the proximal endto the distal end. The stents 101 can have any suitable thickness(es),including a constant thickness.

The configurations of struts 108 and cells shown in FIGS. 46A-46F canenhance the apposition between the electrodes 131 and tissue or vesselwalls when the stents 108 are in their expanded configuration. The strutand electrode configurations 108, 131 can advantageously allow thestents 101 to be compressed into a catheter. The strut and electrodeconfigurations 108, 131 can advantageously allow the stents 101 to beexpanded after being compressed in a catheter. The cells (e.g., theirsize and/or shape) and the electrode 131 positions can allow the stents101 to compress and/or expand so that the struts and electrodes 108, 131do not physically interfere with the compression and/or expansion of thestents 101. For example, the relative positions of the cells and theelectrodes 131 can allow the stents 101 to compress and/or expandwithout getting stuck in a partially compressed configuration or apartially expanded configuration. The cells and the electrode 131positions can help prevent electrodes and struts 131, 108 from becomingsnagged with one another during compression or expansion of the stents101. The relative positions of the cells and electrodes 131 canfacilitate expansion and/or compression of the stents 101. The strutscan be curved and/or straight. The struts that define the cells can becurved and/or straight.

To reduce the number of leads/wires from the stent 101 to externalequipment, a multiplexing unit (not shown) can be used. The multiplexingunit can be placed on the connection panel/paddle of the stent 101(e.g., second panel 224). The multiplexing unit can be placed on thestent 101, for example, on a strut 108. One or multiple multiplexors canbe used. The multiplexing unit can be small enough so that it does notimpede the radial force and flexibility of the stent 101. Multiplexingcan reduce the number of wires required. One or more wires can be usedwith a multiplexor to power and switch between the electrodes 131 asrequired. The stent 101 can be wirelessly powered.

FIGS. 46A-58D illustrate various arrangements of stent cells, but anyopen cell configuration is appreciated. Moreover, although not shown,one or more of the stent cells can be closed such that there is not anopening in the cell. For purposes of illustration, the stents 101 shownin FIGS. 46A-58D are illustrated as having various lengths and variousnumbers of electrodes 131. However, other lengths, greater or smaller,as well as other numbers of electrodes, more or less, are alsoappreciated. The stent lengths shown in FIGS. 46A-58D is not limiting.The length of the stents 101 can be increased, for example, by includingmore stent in the longitudinal direction. For example, the length of thestents 101 can be increased by increasing the number of cells and/or byincreasing the length and/or width of the cells. Similarly, length ofthe stents 101 can be decreased, for example, by having less stent inthe longitudinal direction. For example, the length of the stents 101can be decreased by decreasing the number of cells and/or by decreasingthe length and/or width of the cells. The open cell designs in FIGS.46A-58D are for illustrative purposes only as well. The cellarrangements shown can be repeated, changed, and/or altered to achievethe desired length of the stents 101 and/or the desired open celldesign. FIGS. 46A-58D illustrate various cell shapes and sizes, but anyopen cell configuration for the stents 101 is appreciated. For example,any of the cells in FIGS. 46A-58D can be combined with one another toform a stent (e.g., stent 101). The numbers of electrodes in FIGS.46A-58D can be increased or decreased as needed. For example, the stents101 in FIGS. 46A-58D can have between 1 and 32 or more electrodes 131(the numbers of electrodes 131 in the figures are exemplary only). Inthis way, the stents 101 can advantageously accommodate various vesselphysiologies and sense and/or stimulate various tissues in one ormultiple locations.

The stents 101 can have one or more sections of electrodes 131. The oneor more sections can be separated by one or more sections of struts 108that do or do not have electrodes.

As described above, the stents 101 disclosed and contemplated herein,for example, the stents 101 shown in FIGS. 46A-56D, can stimulate and/orsense various activity of media (e.g., tissue and/or fluids). Forexample, the stents 101 can stimulate and/or sense activity of fluidinside a lumen of a vessel, activity of a vessel itself, and/or activityof media (e.g., tissue and/or fluids) outside of the vessel such as themotor and/or sensory cortex of the brain.

FIG. 46A illustrates that the stent 101 can have seven electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated (e.g., between 1 and 32 or more electrodes). The sevenelectrodes 131 can span radially across a length of the vessel with noelectrode overlap. For example, the seven electrodes 131 can spanradially across a length of an 8 mm vessel with no electrode overlap.The seven electrodes 131 can be at different radial positions along alength of the stent 101 such that there is no overlap of electrodes 131when the stent 101 is expanded in a vessel. The seven electrodes 131 canbe at different circumferential positions along the length of the stent101 such that there is no overlap of electrodes 131 when the stent 101is expanded in a vessel. As described above, this can advantageouslyensure that the stent 101 has a sufficient number of electrodes 131pointing to information rich areas of the brain (e.g., the motor cortex,the sensory cortex, among other areas) upon expansion from a compressedconfiguration.

FIG. 46A illustrates that the stent 101 can have large cells and smallcells. The small cells can be inside the large cells. The struts 108 candefine the cells. Some of the struts 108 can define at least a portionof a small cell and at least a portion of a large cell. Some of thestruts 108 can define at least a portion of a small cell or at least aportion of a large cell. The electrodes 131 can be located on the smallcells and/or the large cells. For example, the electrodes 131 can beintegrated with the small cells. The electrodes 131 can be locatedanywhere on the small cells. For example, the electrodes 131 can belocated at an apex of the small cells. The electrodes 131 can be locatedanywhere on the struts 108. As shown, the electrodes 131 can be locatedat the distal longitudinal apexes of the small cells. Although notshown, the electrodes 131 can be located on a portion of the small cellsaway from the distal longitudinal apexes, including for example, thetransverse and proximal apexes. The electrodes 131 can be indirectlycoupled to the large cells. The small cells can be inside the largecells for advantageous electrode placement and to assist withelectrode-vessel wall apposition. The stent 101 can have a full set ofsmall closed cells on top for stent overlap (e.g., the top row of smallclosed cells in FIG. 46A). The small cells can have a cell length L anda cell width W. The stent 101 can have a total length TL and a totalwidth TW. The configuration in FIG. 46A can enhance the appositionbetween the electrodes 131 and the tissue of a vessel wall.

FIG. 46B illustrates that the stent 101 can have sixteen electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated. The electrodes 131 can be positioned in bipolar pairs forneural recording and stimulation efficiency. The bipolar pairarrangement can advantageously enable direct stimulation or recordingfrom one electrode to another (e.g., between any two electrodes 131).This can elicit a response or record a signal from a focal region of thebrain in a region between the electrodes 131 that form the bipolar pair(as opposed to an electrode 131 and a distant ground, with the second orreturn electrode placed off the stent). The electrodes 131 can beindependent from one another. The electrodes 131 can be used in pairs.The electrodes 131 can be used in multiple pairs, for example, byswitching among the electrodes 131. The electrodes 131 can be used inpairs and can be independent from one another. The configuration in FIG.46B can enhance the apposition between the electrodes 131 and the tissueof a vessel wall.

FIG. 46C illustrates that the stent 101 can have 14 electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated. The electrodes 131 can be positioned in bipolar pairs. Thestent 101 of FIG. 46C is similar to the stent 101 of FIG. 46B, exceptthat the bipolar electrode pairs are constructed with one electrodemounted to an open cell and another electrode mounted in an open cellstyle to that electrode to enhance electrode apposition while ensuringknown distance between electrodes.

FIG. 46D illustrates that the stent 101 can have 16 electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated. The electrodes 131 can be positioned in bipolar pairs. FIG.46D illustrates that the stent 101 can have a straight, single strutbipolar pair open cell design. The electrodes 131 can be mounted on theinside of open cell struts with a bipolar pair electrode 131 attachedwith single linear strut 108. This can reduce the amount of materialrequired (compared, for example, to the amount of material required forthe stent 101 illustrated in FIG. 46C). The configuration in FIG. 46Dcan enhance the apposition between the electrodes 131 and the tissue ofa vessel wall.

FIG. 46E illustrates that the stent 101 can have 16 electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated. The electrodes 131 can be positioned in bipolar pairs. Thecells of the stent 101 can have the shapes shown. The electrodes canhave the locations shown, although any location on struts 108 definingthe cells is appreciated. The stent 101 can be flexible and require lessmaterial that the stents 101 illustrated in FIGS. 46A-46D. Theconfiguration in FIG. 46E can enhance the apposition between theelectrodes 131 and the tissue of a vessel wall. For example, theconfiguration in FIG. 46E can appose the vessel wall around vascularchordae which maintaining superelasticity, at least partly to the largeopen cell design.

FIG. 46F illustrates that the stent 101 can have sixteen electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated. The stent 101 of FIG. 46F is similar to the stent 101 ofFIG. 46A except that the stent 101 of FIG. 46F can have a greater lengthand is illustrated with more electrodes 131.

FIGS. 47A-47F illustrate variations of stents 101 having variouselectrode 131 configurations. The stents 101 of FIGS. 47A-47F aresimilar to the stents 101 of FIGS. 46A-46F except for the different cellconfigurations and electrode 131 locations. FIGS. 47A-47F illustratethat the stents 101 can have strut crosslinks 109 that are offset fromone another, for example, by offset angles 304. The offset crosslinks109 can advantageously allow the stents 101 to be compressed withouthaving any stent overlap. This can, in turn, advantageously allow thestents 101 to be more easily expanded by preventing or otherwisereducing the risk of cells and/or electrodes 131 from becoming entangledor snagged with one another when the stents 101 are expanded. Forpurposes of illustration, the stents 101 in FIGS. 47A-47E have beenillustrated with linearly arranged struts 108, forming various diamond-and rectilinear-shaped cells. However, the cells of the stents 101 canbe shaped as shown in the lower left insets of figures 47A-47F, whichare similar to the small cells of FIGS. 46A-46F except for the offsetangles 304 described above. The offset angle can be, for example, 101degrees (e.g., 101.3 degrees), although other offset angles, more orless, are also appreciated (e.g., 80 degrees to 120 degrees, or narroweror wider ranges).

FIGS. 47A-47F illustrate that the length to width ratio of the cells canbe 7:5. The 7:5 ratio helps ensure that the stents 101 can compress andexpand.

FIGS. 47A-47F illustrate that the stents 101 can have a fork angle 302.FIG. 47A shows that the stents 101 can have a first fork angle 302F anda second fork angle 302S. The first and second fork angles 302F, 302Scan be the same or different from one another. As shown, the first andsecond fork angles 302F, 302F can be measured, for example, between acenter axis and first and second struts (not separately labeled) thatextend from the connection panel 224. The first and second fork angles302F, 302S can each be from about 30 degrees to about 50 degrees. Forexample, the first fork angle 302F can be about 41.5 degrees and thesecond fork angle 302S can be about 35.5 degrees. Other fork angles,more or less, as well as other fork angle ranges, narrower or wider, arealso appreciated. The fork angle 302 can advantageously allow for easierdeployment (e.g., expansion) and retraction (e.g., compression) of thestents 101.

FIG. 47B illustrates that the stent 101 can have sixteen electrodes 131arranged as shown. Other numbers of electrodes, more or less, are alsoappreciated. The sixteen electrodes can be arranged in a ladder stylehaving two or more “rungs.” For example, the sixteen electrodes can bearranged in five rungs of electrodes 131 having a 2-4-4-5-1 pattern. Thestent 101 can have any number of rungs and any number of electrodes 131in each of the rungs, including four rungs having a 2-4-5-5 electrodepattern. As another example, FIG. 47C illustrates that the stent 101 canhave sixteen electrodes arranged in five ladder rungs having a 1-3-3-4-5electrode pattern. The 1-3-3-4-5 pattern of FIG. 47C can advantageouslyprovide additional electrical evaluation length (e.g., stimulationand/or recording length) relative to shorter ladder configurations, forexample, the 2-4-5-5 pattern of FIG. 47B. The ladder style canadvantageously assist with delivery through vascular tortuosity andenable navigation of vascular chordae whilst ensuring electrodeapposition and self-expansion.

FIG. 47D illustrates that the stent 101 can have ten electrodes 131arranged as shown. The ten electrodes 131 are shown in a 1-2-2-2-3 fiverung ladder pattern, although any ladder pattern having ten electrodesis appreciated. The stent 101 can have relative cell sizes similar tothe large and small cells described above with reference to FIG. 46A.

FIG. 47E illustrates that the stent 101 can have sixteen electrodes 131arranged as shown. FIG. 47E illustrates that the stent 101 can havelarger cells on the border (e.g., perimeter) of the stent 101 and moredense cells closer to the center (e.g., in the center) of the stent 101.This arrangement of cells and electrodes 131 can advantageously providean enhanced region for recording or stimulation closer to the center ofthe stent 101. As shown, the electrodes 131 can be arranged in an eightrung 1-2-3-2-3-2-1-2 ladder pattern, although any ladder pattern havingsixteen electrodes 131 is appreciated.

FIG. 47F illustrates that the stent 101 can have sixteen electrodesarranged in seven ladder rungs having a 2-1-4-2-2-3-2 electrode pattern.The 2-1-4-2-2-3-2 pattern of FIG. 47F can advantageously provideadditional electrical evaluation length (e.g., stimulation and/orrecording length) relative to shorter ladder configurations, forexample, relative to the ladder patterns of FIG. 47B-47D. FIG. 47Fillustrates fork angles 302F, 302S that assist with delivery, retractionand deployment, skewed electrode locations for improved deliverabilityand reducing overlap, interleaved cells for overlap and radial force,cell aspect ratio for deliverability and self-expansion.

For purposes of illustration, the stents 101 in FIGS. 46A-47F describedabove and FIGS. 48A-48B, 46B-46C, 51B, 52B, 53B-53C, 54A-57 and 58Cdescribed below are shown flat so that the cells, struts 108, electrodes131, and/or electrode tracks 236 can be easily seen. However, the stents101 are curved in practice (e.g., when in the compressed and/or expandedconfiguration). The top of the stents 101 can be directly joined to thebottom of the stents 101 (the top and bottom as shown in FIGS. 46A-47F)to form cylindrical tube-like stent structures that can exert radialoutward forces against a vessel wall. The top of the stents 101 cancurve around to meet (with or without permanent attachment) the bottomof the stents 101. A portion of the top and bottom of the stents 101 canoverlap or there can be a gap therebetween.

FIGS. 48A-48D illustrate a variation of a stent 101. FIG. 48Aillustrates that the stent 101 can have eight electrodes 131 arranged asshown. The stent 101 can have a proximal end 250 and a distal end 260.The proximal end 250 can include a second panel 224 as described above.The second panel 224 can have stent pads 238. FIG. 48B illustrates thestruts 108 of FIG. 48A that have electrode tracks 236. For purposes ofillustration, the stent 101 is shown flat in FIGS. 48A and 48B but canbe curved as described above. FIG. 48C is a magnified view of theproximal end 250 of the stent 101 of FIG. 48A at section 48C-48C andshows the electrode tracks 236 electrically connected to the stent pads238. An overlay 222 can be placed over the stent pads 238. FIG. 48D is amagnified view of an electrode 131 of FIG. 48A at section 48D-48D.

FIGS. 49A-49C illustrate a variation of a stent 101 having sevenelectrodes 131 arranged as shown. The stent 101 of FIGS. 49A-49C issimilar to the stent 101 of FIG. 46A. FIG. 49A illustrates a perspectiveview of the stent 101 having a curved profile in an expandedconfiguration. FIG. 49B illustrates the stent 101 in a flatconfiguration. FIG. 49C illustrates the struts 108 of FIGS. 49A and 49Bthat have the electrode tracks 236. FIGS. 49B and 49C illustrate thatthe struts 108 can get thicker from the distal end 260 to the proximalend 250, for example, to accommodate multiple electrode tracks 236 asthey merge into a common strut and/or to increase the axial and radialforces/resilience of the stent 101. Multiple electrode tracks 236 on acommon strut can be parallel to each other.

FIGS. 50A-50C illustrate front perspective, rear perspective and topviews of a variation of a stent 101 connected to a connection panel 220.The stent 101 can have eight electrodes 131 arranged as shown.

FIGS. 51A and 51B illustrate a variation of a stent 101 having eightelectrodes 131 arranged as shown. FIG. 51A illustrates a perspectiveview of the stent 101 having a curved profile in an expandedconfiguration and FIG. 51B illustrates the stent 101 in a flatconfiguration. The stent 101 can have a reinforced section 62. As shown,the electrode tracks 236 from each of the electrodes 131 can merge intothe reinforced section 62. The multiple electrode tracks 236 in thereinforced section 62 can be parallel to each other. Some of the struts108 and/or the reinforced section 62 can get thicker from the distal end260 to the proximal end 250. The stent pads 238 can be directlyconnected to the lead wires 141 of a connector 200 (not shown). Thestent pads 238 can be indirectly connected to the lead wires 141 of aconnector 200 (not shown).

FIGS. 52A-52C illustrate a variation of a stent 101 having sixteenelectrodes 131 arranged as shown. The proximal end 250 can include asecond panel 224 as described above. The second panel 224 can have stentpads 238. FIG. 52A illustrates a perspective view of the stent 101having a curved profile in an expanded configuration and FIG. 52Billustrates the stent 101 in a flat configuration. The stent 101 canhave a reinforced section 62. FIG. 52B illustrates that some of theelectrode tracks 236 can merge into a top, bottom, or middle strut 108,or any other strut. The middle strut 108 can be the reinforced section62. Some of the struts 108 and/or the reinforced section 62 can getthicker from the distal end 260 to the proximal end 250. FIG. 52C is amagnified view of the proximal end 250 of the stent 101 of FIGS. 52A and52B and shows the electrode tracks 236 electrically connected to thestent pads 238. An overlay 222 can be placed over the stent pads 238.The stent pads 238 can be directly connected to the lead wires 141 of aconnector 200 (not shown). The stent pads 238 can be indirectlyconnected to the lead wires 141 of a connector 200 (not shown).

FIGS. 53A-53D illustrate a variation of a stent 101 having sixteenelectrodes 131 arranged as shown. FIG. 53A illustrates a perspectiveview of the stent 101 having a curved profile in an expandedconfiguration. FIG. 53B illustrates the stent 101 in a flatconfiguration. FIG. 53C illustrates the struts 108 of FIGS. 53A and 53Bthat have electrode tracks 236. FIG. 53C illustrates that some of theelectrode tracks 236 can merge into a top strut and some of theelectrode tracks 236 can merge into a bottom strut. FIG. 53D is amagnified view of the proximal end 250 of the stent 101 of FIGS. 52A and52B and shows the electrode tracks 236 electrically connected to thestent pads 238.

FIGS. 54A and 54B illustrate a variation of a stent 101. FIG. 54Aillustrates that the stent 101 can have eight electrodes 131 arranged asshown. Other numbers of electrodes, more or less, are also appreciated.FIG. 54B illustrates the struts 108 of FIG. 54A that have electrodetracks 236. FIG. 54B illustrates that some of the electrode tracks 236can merge into a top strut and some of the electrode tracks 236 canmerge into a bottom strut.

FIGS. 55A and 55B illustrate a variation of a stent 101. The stent 101of FIGS. 55A and 55B is similar to the stent 101 of FIGS. 54A and 54Bexcept that the cells in FIG. 55A have a uniform size.

FIGS. 56A-56D illustrate various variations of stents 101 withoutelectrode tracks. The stents 101 can have electrodes 131 arranged asshown. Other numbers of electrodes, more or less, are also appreciated.

FIG. 57 illustrates a variation of a lattice structure for a stent 101.

FIGS. 58A-58C illustrate a variation of a stent 101 having sixteenelectrodes 131 arranged as shown. The stent 101 of FIGS. 58A-58C issimilar to the stent 101 of FIG. 47F. FIGS. 58A and 58B illustrateperspective and side views of the stent 101 having a curved profile inan expanded configuration. The curved profile can have a gap 240. FIG.58C illustrates the stent 101 in a flat configuration. The stent 101 canhave the various dimensions shown (in millimeters) in FIG. 58C.

Any of the stents 101 disclosed and/or contemplated herein can bewireless stents (also referred to as wireless electrode systems). Thestents 101 can have one or more wireless transmitters (e.g., thewireless transmitter 1002 of FIG. 31). The wireless transmitters can beattached to or integrated with the stents 101. The wireless transmitterscan be a separate device and/or can be an arrangement of one or moreelectrodes 131 of the stents 101. For example, an arrangement of one ormore electrodes 131 can form a wireless antenna that can send and/orreceive information. The electrodes 131 can record or pick up neuralinformation and relay this information to a wireless transmitter. Thisrecorded information can be wirelessly transmitted through the skull toa wireless receiver (e.g., the wireless receiver 1004 of FIG. 31). Thewireless receiver can decode and transmit the acquired neuralinformation to a device such as a prosthetic limb or a visualprosthesis.

The wireless stents (e.g. stents 101) can be configured for thetransmission of both power and data. Power can be wirelessly transmittedto the wireless stents to operate the circuitry of the stents and datacan be wireless transmitted from the wireless stents to, for example, acontrol unit (e.g., control unit 12). In addition to or in lieu of thewireless power, the stents can be powered with a piezoelectric energypower generator that generates energy from blood flow and/or fromvascular constriction and dilation.

The wireless stent systems can be fully or partly wireless. Fullywireless means that no portion of the stent (e.g., stents 101),including the electrodes 131 and wireless circuitry, extends beyond avessel wall after implantation. Semi-wireless means that at least aportion of the stent (e.g., stents 101), electrodes 131 and/or wirelesscircuitry extends beyond a vessel wall after implantation. The stent 101of FIG. 31 is an example of a fully wireless stent system. As shown inFIG. 31, the entire device (stent and electronics) can be within theblood vessel, or otherwise become embedded within the blood vessel overtime. The stent 101 of FIG. 2A is an example of a semi-wireless system,where the wireless electronics sit outside the vessel in the pectoralregion. The system of FIG. 2A is similar to, for example, a pacemakerwhere the wireless system sits outside of the vessel. Semi wirelesssystems can have a wire that passes from within a blood vessel tooutside a blood vessel.

As described above, the stents 101 can be used to scaffold theelectrodes 131 against the vessel wall. Wireless stent systems can haveone or more stents (e.g., stents 101), for example, between one and tenstents (e.g., 1, 2, or 3 or more stents 101). Other numbers of stents,more or less, as well as ranges, narrower or wider, are alsoappreciated. If the wireless electronics cannot be mounted on orintegrated with a first stent 101 having electrodes 131 (e.g., due tospace or functional requirements), the wireless electronics can bemounted or integrated with a second stent 101 (e.g., which can have thesame or a different number of electrodes than the first stent 101, or noelectrodes). Such multi-stent systems (e.g., dual-stent systems) canadvantageously carry the circuitry away from the center of the vesselwhere it has a chance of causing occlusion or blockage. The first andsecond stents of a dual-stent system can advantageously form a dipoleantenna, which can improve wireless transmission of the system. Thesecond stent can be under the skull connected directly (but notelectrically) to the first stent, or can be placed in the neck, tetheredto the first stent. Other arrangements are also appreciated (e.g., thefirst and second stents can be electrically connected to one another). Abenefit of placing the second stent in the neck includes a reduction indistance to the body surface. Placement in the neck is also expected tocause less interference to the acquisition and amplification of theneural signals.

The system (e.g., system 10) can have one or more stents 101 in wiredand/or wireless communication with a telemetry unit (e.g., control unit12). For example, the system can be an endovascular telemetry and closedloop cortical recording and/or stimulation system for the diagnosis,prediction and treatment of epilepsy. Endovascular telemetry systems forepilepsy (also referred to as epilepsy care systems) can advantageouslyrecord brain activity 24 hours/day 7 days/week. This 24/7 monitoringoffers a critical advantage to doctors and patients alike, astraditionally the ability of the treating physician to determine thenumber of seizures a patient is suffering depends on the patientrecording a seizure diary, which can be, and are notoriously,inaccurate. Knowing how many and the nature of seizures occurring in apatient can be critical in determining the correct dosing foranti-seizure treatment by the physician, which the endovasculartelemetry system provides. The epilepsy care systems can receive inputsthat can modulate treatment doses of medications/drugs.

For recording telemetry, a stent 101 can be implanted in cortical venoustargets (including the transverse sinus) to achieve proximity tocortical regions of interest for seizure detection (including thetemporal lobe). The stent 101 can be or can be part of an implantabletelemetry unit (ITU). The ITU can house a data unit that can collectbrain recordings 24/7. The ITU can be accessed wirelessly by the user orphysician to review the neural information over a time period ofinterest. The ITU can be accessed wirelessly for real-time assessment ofthe neural information. For example, in periods of higher-risk(including when the patient is unwell, or having to make modificationsto their treatment regimen) the physician is able to assess neuralsignal in real time. The neural data collected by the ITU can bestreamed into a range of apps that allow various real time functions.For example, the neural data collected can be communicated to thirdparty applications that apply software analysis of the neural data(including for seizure prediction). In this way, the collected data canbe made available to third party users to generate information ormodulation information to the patients upon use of the collected data.The epilepsy care systems can have closed loop feedback. For example,the collected data can be utilized in an input loop into atreatment-delivery system to enable precise dosage determinations basedupon data containing real-time seizure detection (including vagal nervestimulator, drug delivery systems). The epilepsy care systems canperform neuromodulation. For example, responsive neural stimulation canbe achieved by the endovascular systems described herein having stents101. This can advantageously enable a closed loop system by utilizingthe stent system to record and deliver treatment by stimulating acrossthe vessel wall (e.g., from one or more electrodes 131 of one or morestents 101) to achieve seizure termination.

FIGS. 59A-59C illustrate a telemetry unit lead 400 having a snake andrung design connected to a telemetry device 12. The snake and rungdesign can advantageously reduce the surgical manipulation required toshorten the lead 400, for example, if the lead is too long. Typically,leads are shortened by winding the lead on itself; however, such windingcan cause fatigue as the lead rubs on itself and wears away and/or canrequire a larger incision into muscles during surgery. The snake andrung design prevents/avoids these risks. As shown in FIGS. 59A-59C, thetelemetry unit lead 400 can be a set overall size (e.g., overall length)that is curled into a snake form 404 connected by one or more rungs 402.The rungs 402 can be made of silicone or other biocompatible materialthat has some flex. If a longer lead is required, one or more of therungs 402 can be detached (e.g., through surgical cutting or otherwise)so that the lead length can be increased. In this way, the length of ageneric telemetry unit lead 400 can be tailored/customized to a patientand to the surgical placement of the telemetry device 12 during surgery.For example, FIGS. 59A-59C illustrate that the lead length can beincreased from L₁ to L₂ by detaching four rungs 402, for example, duringsurgery. One or more rungs 402 (e.g., one, two, or three or more) can beplaced centrally or on the left and/or right edges of the snaked portion404 of lead 400, or somewhere in between.

As described above, the telemetry unit (e.g., control unit 12) cancommunicate information (using wires or wirelessly) to and/or from anexternal apparatus 16, which can include (but is not limited to) one ormore of the following: (a) an exoskeleton; (b) wheelchair; (c) computer;and/or (d) other electrical or electro-mechanical device.

For example, FIGS. 60a-60d illustrate a variation of a system 10 havinga stent 101 implanted in the vascular of a person's brain, for example,a vessel traversing the person's superior sagittal sinus. FIG. 60aillustrates the system 10 and FIGS. 60b-60c illustrate three magnifiedviews of the system 10 as shown. The stent 101 can be implanted forexample, via the jugular vein, into the superior sagittal sinus (SSS)overlying the primary motor cortex to passively record brain signalsand/or stimulate tissue. The stent 101 can record and interpret brainsignals that are associated with intentions to move, so that people whoare paralyzed due to neurological injury or disease, can communicate,improve mobility and potentially achieve independent through directbrain control of assistive technologies such as computer software and/orapparatuses 16 (e.g., robotic upper limb prostheses, motorizedwheelchairs, and the like). Other applications for the stent 101 asdescribed throughout this disclosure are also appreciated.

The system 10 can have one or multiple telemetry units. The system 10can have one or multiple internal and/or external telemetry units. FIGS.60a and 60d illustrate that the system can have an internal telemetryunit (e.g., control unit 12) in wired or wireless communication with anexternal telemetry unit 15. For example, the external telemetry unit 15can be wirelessly connected to the internal telemetry unit 12 across theuser's skin. The internal telemetry unit 12 can be in wireless or wiredcommunication with the stent 101. For example, FIGS. 60a-60d illustratethat the stent 101 can be electrically connected to the internal controlunit 12 via a communication conduit 14. The communication conduit 14 canbe a stent lead. As shown in FIG. 60c , the stent lead can extend fromthe stent 101, pass through a wall of the jugular, and tunnel under theskin to a subclavian pocket. In this way, the communication conduit 14can facilitate communications between the stent 101 and the internalcontrol unit 12.

As shown in FIGS. 60a-60d (as well as FIGS. 1-2B), the one or multipletelemetry units can be located/implanted in and/or on the chest of auser. However, the telemetry unit can be located in any suitablelocation. For example, the telemetry unit can be located/implantedbehind the ear of a user. For example, one or multiple telemetry unitscan be located/implanted behind the ear of the user at, or otherwiseproximate to, location 19 shown in FIG. 60a . Relative to placement inand/or on the chest, positioning the control unit behind a user's earcan advantageously reduce artifacts and noise due to neck and musclemovement, for example, because the communication conduit 14 (e.g., stentlead) would not need to be located in the neck of a user.

The internal telemetry unit 12 can be connected to one or multipleexternal apparatuses 16. The internal telemetry unit 12 can be connectedto one or multiple internal apparatuses (not shown), for example, visualprosthetics and other controllable devices implanted partially orcompletely within or on a person's body. The external telemetry unit 15can be connected to one or multiple external apparatuses 16. Theexternal telemetry unit 15 can be connected to one or multiple internalapparatuses (not shown), for example, visual prosthetics and othercontrollable devices implanted partially or completely within or on aperson's body.

As described above, the system (e.g., system 10) can have one or morestents 101. The stents 101 can be in wired and/or wireless communicationwith a telemetry unit (e.g., control unit 12). The stents 101 can recordand or stimulate areas of the cortex associated with vision. Forexample, the system can be an endovascular visual prosthesis neuralinterface having one or more stents 101. The stent 101 can be used toaccess deep, folded areas of cortex in the occipital lobe (e.g., theprimary visual cortex) that are not reachable via open brain surgery,and which cannot be targeted by current technology (i.e., technologythat is implanted directly onto the cortical surface of the occipitallobe). FIG. 34 shows a method for stimulation and the recording neuralinformation or the stimulation of neurons from the visual cortex of apatient using the device 100, including the steps of: (a) implanting thedevice in a vessel in the visual cortex of the patient; and (b)recording neural information associated with the vessel or stimulatingneurons in accordance with received stimulation data. The stents 101 canbe implanted in the superior sagittal sinus and/or the transverse sinusto advantageously achieve transvascular stimulation of the occipitalregion of interest, although any implant location is appreciated.Information from the visual world can be captured in a video capture.The information can be translated into a stimulation algorithm. Thetranslated information can be delivered into the occipital lobe viastimulation via one or more stents 101. The visual prosthetic system cancontain a large number of electrodes embedded into the wall of thetransverse and superior sagittal sinus via the one or more stents 101.

The one or more stents 101 can be used for an endovascular neuralinterface system for deep brain stimulation treatment. Current deepbrain stimulation requires a craniotomy for implantation of the leads.Craniotomy procedures are associated with myriad complications and risksincluding hemorrhage. The stents 101 can eliminate the need forcraniotomies. The stents 101 can access to deep structures suitable astargets for deep brain stimulation is viable through deep venous andarterial vessels in the brain. A catheter can be used to access the deepblood vessels. The stents 101 can enable stimulation of targeted braintissue. Implantation of an endovascular lead into a deep structure canenable stimulation of the brain tissue. The stents 101 and systemsdisclosed herein can treat a range of conditions with deep brainstimulation, including Parkinson's disease, dystonia, obsessivecompulsive disorder, depression, among others.

FIG. 61A illustrates a variation to the overall stent structure. In thisvariation, the stent structure 101 includes a single radius R but thestent structure is spaced or contiguous. This configuration allows thestent structure to accommodate a greater size range of vessels. FIG. 61Billustrates a stent structure 101 having a first portion (such as ahalf) with a greater radius R2 than the radius R of the other portion(or other half). This configuration allows the structure 101 to curl onitself in one direction preferentially, which is anticipated to: reducethe force to retract into catheter; reduce the likelihood of electrodesor struts catching; and/or enable a larger diameter (increased radialforce) without requiring an increase in overall physical stent size oroversizing of stent.

FIGS. 62A-62B illustrate an improvement to the electrodes 131 areconfigured with one or more filleted edges 116 that transition from theelectrode to adjacent struts 108. FIG. 62A and 42B illustrate respectivefilleted edges on a single side of the electrode and both sides of theelectrode respectively. The filleted edges 116 can be configured as agradual thickening from the strut towards the electrode, therebyremoving a sharp corner and creating a slower, shallower transitionbetween strut and electrode. Thickening of the strut transition 116 andcreating that “smooth corner” reduces the prospect of wires or otheritems being caught in the intersection adjacent to the electrodes.

In some variations of the device, the filleted edges 116 can add to theconductive surface of the electrode. However, in those applicationswhere primary purpose of the edge 116 is to prevent the electrodecatching on alternate stent struts or other structures, the filletededge 116 can be non-conductive.

FIG. 63 illustrates a variation of a stent device 100 with a stent shaft121 that has grooves or pockets 125 (e.g., areas of the shaft 121 thatare removed.) The grooves or pockets 125 allow for the epoxy/adhesive toreduce movement in multiple planes (i.e., both left /right andforward/backwards). The toothed pattern increases the grip when attachedto a lead because epoxy/adhesive can be deposited between the teeth.This makes the attachment to the lead more secure and stable, whilemaintaining the existing geometric profile and width.

FIG. 64 illustrates a planar view of a variation of a stent device 100where the electrodes 131 are specifically designed to limit the numberof tracks per strut 108. Limiting the number of tracks per strut 108reduces potential crosstalk and noise caused with/by parallel tracks andalso reduces the width of the strut that is required to support multipletracks. In certain variations, the tracks/struts are located/positionedin a unidirectional arrangement to: reduce thermal heating generated byhigh angle turns and reduce fatigue caused during flexion/extension. Thetrack thickness can be optimized to minimise the electricalresistance/impedance (where large tracks better) as well as minimize theoverall strut thickness (where small tracks are better).

FIG. 65 illustrates an implantable telemetry unit 12 coupled to aconnector via an extension lead 14. In this variation, the lead 14 isarranged in a serpentine fashion, connected by a thin (possibly polymer)layer, with thicker ‘bridges’ 17 across each lead pass. This allows asurgeon to pull the required length of lead from the ITU body, withoutrisking fatigue due to lead rubbing, and minimising the depth of asurgical pocket needed for implantation of the device.

Other Applications

The methods, device, and systems described herein are discussed in termsof controlling computers, wheelchairs, exoskeletons, robotic prosthesis,cameras, vehicles and other electrical stimulation, diagnostic andmeasurement hardware and software. However, specific applications ofthese methods, systems and devices can provide languagecommunicators/translators, gaming and (house) device controller,enhancements to applied intelligence and memory, sleep modifications,integrated communication devices, as well as enhanced cognitive outputdevices.

In some variations, the implants record neural activity, which transmitssignals representing the neural activity to another source (whetherexternal or internal). Next, feedback is provided to the patient/user.In one basic variation, the signals representing neural activity can betransmitted to a processing unit that includes a database of previouslydetermined activity. Where the processing unit identifies or comparesthe recorded neural activity to the database of previously determinedactivity and generates a signal to control or trigger an externaldevice.

In the variations discussed above, the neural activity can be monitoredin different areas brain areas that are being recorded from indicativeof different ways that information can be acquired from the brain (i.e.,signals relating to speech, movement, sight, vision, memory, emotions,touch).

Transmitting the signals to the source can include delivering theinformation contained in the signals to a useful external source. Thiscould be a prosthetic limb, or could be more advance (such as a databaseconsisting of information, or language translations etc.). In somevariations, the transmission of signals could comprise the final step(as is the case with rudimentary prostheses such as a wheelchair, forspeech translation or for recording memories, dreams or previous visualinformation).

Various examples of sending feedback to the patient/user can vary basedon the specific application. For example, sophisticated prostheses couldprovide information in the form of tactile feedback to sensory corticeswithin the brain. Alternatively, systems for treatment of moods,depression, or post-traumatic stress disorder provide feedback thatstimulates an area of the brain that provides a feeling of happiness.Feedback could also come in the form of auditory cues (i.e., stimulationcould be delivered back to the person which is interpreted as left,right, straight ahead etc.). Similarly for visual feedback, directionsin the form of arrows could be presented to the visual cortex to informwhich direction to take, or for other applications such as memory, couldprovide a complete (or near complete) scene of what you need to recall(where you live, where your car is parked, what was on the shopping listetc.). Signals generating low resolution images (e.g., around 1500pixels), which could be used to spell words or general shapes thatprovide the desired feedback/Other useful cues can be delivered tojustify electrical stimulation as visual feedback (i.e., flashing ofnumbers or symbols representing numbers). Clearly, the systems describedherein can apply to medical applications as well as non-medicalapplications.

Universal Translators

The applications of one or more neural implants can assist thoseindividuals who cannot communicate verbally by enabling direct braincontrol of speech or other communication. In such a case, the implantsdescribed above can function with a device that provides universaltranslator capabilities such as enabling people with speech difficultiesto have a voice through a computer. Alternatively, or in combination,the universal translator can sense neural activity and cause stimulationof the individual's own muscles to enable communication. The implantsdescribed herein can record brain activity or signals specific tospeech, relay such activity to an external device that uses signals tocontrol a computer speech processor, a speaker, the user's own muscles,or even cause direct stimulation of a different implant in a differentindividual. For example, the systems can allow for signals of certainneural activity to be transmitted to another person's auditory cortex(e.g., hearing aid, cochlear implant, etc.) so that the neural activityof a first individual can be received by a second individual withouttraditional sounds/speech.

Further, processing of this information can enable communication in anylanguage by translating between two or more different languages. It isknown that neural commands generated by the brain control the musclesused for speech (tongue, lips, mouth etc.). An implant placed in aspecific cortical location, can record signals the brain sends to thesemuscles. Different muscles have a large, but finite, number of differentcombinations meaning that a finite number of commands can drive a speechor control the muscles directly.

Such systems can include applications for people who are mute or havespeech difficulties (stutter, lisp), suppression of unwanted speech(Tourette's), universal translator between different languages.

Gaming and Device Controllers

The systems, methods and devices of the present disclosure can alsoreceive neural activity that controls muscles during high intensitygaming. Such neural activity can be processed to control an externalgaming device or various house appliances and devices (e.g., lightswitches, appliances, locks, thermostats, security systems, garagedoors, windows, shades, etc.) Again, the implants would detect brainsignals specific to acts in which such devices are operated. The systemcan then generate signals to control one or more networked externaldevice that to allow for neural control of the devices.

Memory Assist Systems

The systems described herein can also aid in memory recall of pastactivities. For example, one or more electrode devices can be implantedin regions of the brain that receive information sent by the eyes to thevisual cortex. Neural signals that are generated through the eyes orduring sleep can be acquired within the visual cortex. The visual cortexis retinotopically mapped (i.e. fields of view in the eye have specificcortical locations). Major regions of visual cortex are inaccessible byconventional electrode arrays as it is hidden beneath a large vessel.The sensory devices described herein can access one or more regions thatare otherwise inaccessible by the conventional electrode arrays. Theseneural signals can be relayed to a recording device. At a later time,the recorded signals can then be re-stimulated in various locations inthe brain to replay the visual or other input. Such recording and replaymethods can be applied to any sensory input in addition to visual. Invariations where the system records multiple sensory inputs, the systemcan later relay a sensory recording in isolation or in combination withother sensory recordings. In addition, visual information can bedelivered to a person through stimulation of the visual cortex or otheraccessory areas. This would enable use as a restorative visual implantfor the blind or to enable people to visualise pre-developed scenes(i.e., could see and be immersed in a movie or scenery of a differentlocation.

These systems can assist in individuals where the recall of pastactivities is difficult, such as for people with Alzheimer's ordementia, people who experience physical or psychological trauma whichcauses memory loss. In addition, such a memory assist system can be usedon a temporary basis where a device is implanted only for a short periodof time.

Intelligence Enhancement Systems

Another application of the systems described in this disclosure includesestablishing a connection between the brain and a database, server,and/or an internet site. The system can include using an existingnetworked appliance such as a cell phone and/or networked appliance thataccesses information. As with the other systems described herein, anelectrode device can be positioned in a region of the brain to senseneural activity and determine the intent of the neural activity (such asby comparing the neural activity to previously determined actions),which allows control of the system similar to a spoken command. Thesystem can then stimulate the brain directly based on informationprovided by the database, server, and/or an internet site forapplications including: augmented intelligence, non-verbalcommunication, etc. In this variation, there is two waycommunication—information or a request coming from the sensors locatedin the brain, sent via a computer, database or server, then informationis fed back into the brain (potentially to different targets (i.e. forsight, smell, taste, memory, vision etc.). For example, an individualcan ask a question to a voice activated/recognition computer interface.The computer would then provide feedback using a visual (i.e. arrows tothe visual cortex) or auditory (tones or full commands for left, right,straight etc.) presentation/descriptions of a map or directions to thenearest place.

The networks described herein can comprise a traditional a computernetwork comprising is a set of computers connected together for thepurpose of sharing resources. Alternatively, or in combination, thenetwork can comprise a directly attached equipment (i.e., a robotic limbcan provide information to tell the user that they are touchingsomething). Furthermore, there are databases that may be required to beaccessed (i.e., maps, or general knowledge).

Sleep Stimulation/Suppression Systems

Another application of the systems described in this disclosure includesimplantation of a device within a sleep center of the brain to stimulateor assist in accelerating neural reconfiguration where the stimulationand neural reconfiguration reduce the hours needed to sleep.Alternatively, the systems can be used to keep people awake whererequired.

Integrated Communication Systems

The systems described herein can also function as integratedcommunication systems. The disclosed and contemplated systems canaugment communication for those who cannot communicate, can augmentcommunication for those who can communicate normally, can augmentcommunication for those who can communicate but in a diminishedcapacity, or any combination thereof. For example, the device (e.g.,stent 100) can record neural activity in the motor cortex associatedwith making a call. The neural activity can then be relayed to circuitryeither wired or wirelessly that connects to network and places therequired call. Speech commands, generated through set commands (i.e.,one action for hello, one action for goodbye acquired from motor cortex)or vocal activation can be acquired and sent to receiver. As withprevious descriptions, the voice on the other end of the line could thenrelay words back to the auditory or visual cortex (via electrodes)directly.

As another example, the device (e.g., stent 100) can record neuralactivity in the motor cortex associated with communicating with anelectronic device such as a computer, a database, a server (e.g., a webserver, an internet server, a cloud server), or any combination thereof,as well as with the internet in general, including web pages, websites,search engines, or any combination thereof. The device 100 can recordneural activity in the motor cortex associated with communicating withsoftware stored on one or multiple electronic devices (e.g., on acomputer, in the cloud). For example, for a subject to communicate withand/or navigate the internet, the device 100 can be in communicationwith an intermediary device (e.g., an electronic device) incommunication with the internet. The device 100 can be in wired orwireless communication with an electronic device. The electronic devicecan be a remote electronic device. However, regardless of the proximityto the subject, the electronic devices can be assistive devices that thedevice 100 (also referred to as a brain machine interface) cancommunicate with and/or can be assistive technology such as assistivesoftware that the device 100 can communicate with. A closedcommunication loop can be formed between the device 100 and thecomputers and/or assistive software that the device 100 is configured tocommunicate with.

A subject can communicate with electronic devices and software bycontrolling a moveable control such as a cursor. The device 100 canrecord neural activity in the motor cortex associated with such control.For example, subjects who have the device 100 can communicate withelectronic devices and software by willing cursor movement (e.g., bywilling a mouse cursor to move) and by willing cursor selection (e.g.,by willing a mouse click, including left mouse click functionality,right mouse click functionality, mouse wheel functionality, mouse wheelfunctionality for scrolling, click and drag functionality, or anycombination thereof). In this way, the device 100 can enable a subjectthrough the power of their thought to move a cursor on an electronicdisplay (e.g., computer screen), to make selections on the electronicdisplay via the cursor, or any combination thereof. Subjects can makeselections with a cursor, for example, by “clicking” on a selection, byhovering over a selection for a threshold time period such as 5 seconds,by clicking and then enclosing the selection with a selection shape(e.g., a selection box), or any combination thereof. The electronicdisplay can be a screen of a computer, for example, of a smartphone,tablet, laptop, desktop monitor, television, virtual reality system,augmented reality system, graphic display goggles, graphic displayglasses, graphical user interface, or any combination thereof. Thedevice 100 can record neural signals such that the subject can move oneor multiple cursors and can make one or multiple selections (alsoreferred to as decisions). Where the subject is controlling multiplecursors, the subject can move the multiple cursors sequentially orsimultaneously relative to one another. Where the subject is makingmultiple decisions, the subject can make such decisions sequentially orsimultaneously relative to one another.

A subject's decisions associated with neural activity recorded in theirmotor cortex by the device 100 can include any decision people without adevice 100 can make while interacting with a computer or the internet,such as, for example, selecting links, opening and closing documents,opening and closing emails, browsing websites, selecting links onwebsites, opening and closing software programs, using the softwareprograms (e.g., graphical programs such as graphical word processingprograms, internet browsers, email programs, video games), initiatingand terminating internet connections, or any combination thereof. Inthis way, subjects having the device 100 can control electronic devices,for example, to browse the internet and use software programs.

An example of a software program that a subject can interact with viathe device 100 is communicating software such as a speller. A subjecthaving a device 100 can move a cursor on a display to make letter andword selections in the speller to spell and communicate with others viaone or multiple electronic devices, for example, using programs havingletters, words, and/or drawing features (e.g., a word processingprogram). The speller software can display letters on a screen and thesubject can will a cursor to move on the screen to select the lettersthat they want.

The device 100 can be unidirectional (record only or stimulate only) orcan be bi-directional (record and stimulate). Once the device 100records neural activity, the recorded neural activity can then berelayed to circuitry either wired or wirelessly that directly orindirectly connects to an electronic device or first to a processingunit that includes a database of previously determined activity. Theprocessing unit identifies or compares the recorded neural activity tothe database of previously determined activity and generates a signal tocontrol or trigger an external device. For communication with anelectronic device, feedback may (e.g., when using a bi-directionaldevice 100) or may not (e.g., when using a unidirectional device 100 orwhen using a bi-directional device 100) be sent back to the brain.Visual feedback can be provided on the electronic display of theelectronic device when the subject is communicating with the electronicdevice via the device 100 such that feedback to the brain is notrequired.

Enhanced Cognitive Output

Systems described herein can be used to enhance cognitive output, forimprovements in such areas as: learning, memory, training, motor tasks,etc. Transcranial Direct-Current Stimulation (TDCS) and TranscranialMagnetic Stimulation (TMS) have been shown to have potentialapplications in improved attention, learning, and motor outputs.Implantation of an intravascular stimulation device into the appropriatearea could potentially create more reliable, long term improvements tocognitive outputs using less energy due to increased access andproximity to the regions of interest.

Neural Signal Processing

The systems and implants described herein can record and process neuralactivity to control devices that are internal and/or external to auser's body via a brain machine interface. Such processing can be donewith one or more processors or microprocessors that are, for example,integrated or otherwise in communication with one or more stent devices100 and/or with the telemetry unit 12. The processors can be programmedwith or be capable of calling a variety of control algorithms to processthe neural signals received from the brain and/or from elsewhere in thebody. This includes neural signals received from both the sympatheticand/or parasympathetic pathways. For example, an electrode array (e.g.,the stent based electrode array 100) can sense cortical and/orsub-cortical neural activity, and can relay such activity to a processorto control a brain machine interface. The brain machine interface can belinked to internal and/or external devices. Cortical and subcorticallocations can include, for example, the primary motor cortex (M1), thesupplementary motor area (SMA), the posterior parietal cortex (PPC), theprimary somatosensory cortex (S1), the cerebellum, the thalamus and thebrain stem. Neural activity in areas outside of the brain can also besensed and processed, for example, from the spinal cord, muscles andorgans such as the heart, lungs, stomach, kidneys and pancreas. Thecontrol algorithms can process neural activities that are sensed orrecorded by the system to generate control signals. The generatedcontrol signals can allow for the neural control of one or multipleexternal devices, internal devices, parts of the body, or anycombination thereof. For example, the algorithms can produce controlsignals that actuate some part of a device and/or that stimulate tissue.

The algorithms can process sensed neural activity from one or moreneural areas to determine, for example, whether a user intends to act,and if so how much. If the sensed neural signals correspond to intendedaction, the brain machine interface can generate control signals thatactuate a device associated with the action intended. For example, wherea user has a prosthetic arm linked to a brain machine interface, theuser can think about raising their arm and the system can detect thisintent by processing the neural signals that are associated with thisaction. The system can transform this detected intent into a controlsignal to raise the prosthetic arm according to the user's intendedaction.

Various algorithms can be used to decode or otherwise determine a user'sintent as well as determine whether the sensed or decoded intentcorresponds to a user's intended action. For example, the system cansense signals from multiple brain areas to rely on and detect naturalsynergies that exist between multiple brain areas when a user mentallyforms an intent (e.g., a motor intent). Such an intent determinationalgorithm relies on the fact that any given intent will be replicated inmultiple areas of the brain and be supplemented with additionalinformation. For example, the system can detect and use natural corticaland/or subcortical synergies for informing the outputs of the brainmachine interface when determining intent. In such a case, the systemcan determine a user's intent by processing neural signals from two ormore neural areas and then making a determination of whether the two ormore sets of neural signals are associated with one another beforegenerating an output signal. Sensing and analysing neural synergies canreduce the risk of accidentally activating devices in communication withthe brain machine interface since such a decoding process relies onmultiple areas of the brain as opposed to just one, and takes advantageof the neural redundancies or lack thereof that naturally result.Utilizing such synergies can therefore enable for more accurate andreliable identification of a person's intent. This can in turn allow forthe generation of more accurate and reliable control signals, as well asinstil greater confidence in users for the device. The system can alsodetermine a user's intent without relying on neural synergies, forexample, by processing neural signals from a single area withoutassociating or comparing the signals to signals from other neural areas.

FIG. 66 illustrates a variation of an algorithm 350 for processingneural signals from two or more neural areas that are received, forexample, from one or more stent devices 100. The algorithm 350 canprocess the received neural signals to determine whether the signalscorrespond to a user's intended action. Upon starting at block 352, thealgorithm 350 can record brain signals 354 from multiple neurallocations, decode intents 356 from the recorded signals, and perform acorrelation analysis 358 on the intents decoded. For example, FIG. 66illustrates that the algorithm 350 can record brain signals 354 from afirst location 354 a and a second location 354 b. The neural activity indifferent areas can be recorded simultaneously or sequentially relativeto activity recorded in one or more other areas (e.g., the signals atthe second location 354 b can be recorded at the same time as thesignals at the first location 354 a or at a later time).

Recording signals from multiple neural areas 354 makes the algorithm 350multimodal and enhances the intent determination process 356 andimproves error detection 358. The recorded signals can be measured, forexample, with one or more sensors (e.g., one or more electrodes 131 ofone or more stent devices 100). For example, the brain signals in thefirst location 354 a can be recorded with a first sensor and the brainsignals in the second location can be recorded with the first sensor ora second sensor. The first sensor can be proximate or in the firstneural area 354 a and the second sensor can be proximate or in thesecond neural area 354 b. Further, although FIG. 66 illustrates that thefirst and second neural areas 354 a, 354 b are in the brain, the neuralareas 354 can be in and/or outside of the brain including, for example,the cortex, the subcortex, the cerebellum, the thalamus, the brain stem,the spinal cord, organs, muscles, or any combination thereof. The firstand second neural activities 354 a, 354 b can be measured with the sameor different implants, for example, with first and second stent devices100.

Once the first and second signals 354 a, 354 b are received in step 354,the algorithm 350 can determine the intents 356 that are associated witheach of the recorded signals. For example, FIG. 66 illustrates that afirst intent 356 a can be determined from the first neural signal 354 aand that a second intent 356 b can be determined from the second neuralsignal 354 b. The first and second intents 356 a, 356 b can bedetermined by decoding the recorded first and second neural activities354 a, 354 b, respectively. Alternatively, or in combination, theintents 356 (e.g., first and second intents 356 a, 356 b) can bedetermined by referencing previously measured neural activities storedin a memory. The neural activities stored in the memory can be obtainedfrom the user, another person, and/or from multiple people. In this way,the stored neural activities can be user specific, specific to anotherperson, and/or be a compilation of data from multiple users. In thisway, the memory can be patient-specific and/or be a global library ofneural data. Where neural data from one or more other people who aredifferent from the user is stored on and/or referenced from the memory,this data can represent a benchmark standard and/or the next neural goalfor the user at any stage in their neural development and training. Thememory can be configured to store new measurements, purge oldmeasurements, organize the stored data, or any combination.

Once the intents 356 are determined, the algorithm 350 can perform acorrelation analysis 358 to determine whether to actuate 360 or notactuate 362 a device associated with or otherwise controllable by thealgorithm 350. The correlation analysis 358 can ascertain error betweentwo or more of the neural areas being recorded, for example, between twoor more of the measured signals 354 and/or between two or more of thedetermined intents 356. FIG. 66 illustrates that if the correlationanalysis 358 determines that the first intent 356 a is the same as orsubstantially the same as (also referred to as associated with orsubstantially associated with) the second intent 356 b, a processor canbe programmed to generate one or more control signals configured toactuate 360 a device. Likewise, if the correlation analysis 358determines that the first and second intents 356 a, 356 b are notassociated with one another, the processor can be programmed to notactuate 362 the device. Stated differently, if the algorithm 350confirms that two or more decoded intents 356 are associated with oneanother, one or more control signals can be generated and delivered tothe device to actuate 360 the device, after which the algorithm 350 canreturn to the recording step 354 or end 364. Likewise, if the algorithm350 is unable to confirm that two or more decoded intents 356 areassociated with one another (e.g., if an error is detected between thetwo or more decoded intents 356), the algorithm 350 can proceed to therecording step 354 or end 364 without actuating 362 the device.

For example, the correlation analysis 358 can calculate an error betweenthe measured first and second activities 354 a, 354 b and/or between thedecoded first and second intents 356 a, 356 b. For example, thealgorithm 350 can deliver one or more control signals to the device upondetermining that the calculated error between the first and seconddecoded intents 356 a, 356 b is below a pre-determined error, upondetermining that the calculated error is below multiple pre-determinederrors, upon determining that multiple calculated errors are below thepre-determined error, upon determining that an average of multiplecalculated errors is below the pre-determined error, upon determiningthat an average of multiple calculated errors is below an average ofmultiple pre-determined errors, or any combination thereof. Thepredetermined error or errors can be determined, for example, usingprediction class matching and/or instrumented class matching. Forexample, the prediction class matching can be binary (e.g., classes canbe class 1-n, where each class can activate a switch). For example, ifthe intended class (e.g., the first decoded intent)=the predicted class(e.g., second decoded intent), then the processor can generate anddeliver control signals to the device. The instrumented class matchingcan also be binary but the intended class can instead be provided by anexternal sensor (e.g., from a proximity sensor or other such device).

FIG. 66 illustrates that the processor can be configured to make a “Yes”and a “No” decision. A “Yes” signal can prompt the processor to transmitone or more control signals to the device to actuate 362 the device. A“No” signal can prompt the processor to return to step 354 of thealgorithm 350. The steps 354, 356, 358 of the algorithm 350 can berepeated until at least one control signal is delivered to the device.The algorithm 350 can start 352 automatically when the stent devices 100are in communication with the devices being controlled, or can becontrolled by the user or another party such as a care provider. Thealgorithm 350 can be used to control one or more parameters of thedevice, for example, a first parameter, a second parameter, a thirdparameter, or more parameters. The parameters can correspond to aposition, velocity, or trajectory of the device (e.g., a first parametercan be a position of the device, a second parameter can another positionof the device, and a third parameter can be a velocity of the device).As described above, the device can be an exoskeleton, a prosthetic limb,a speller, a wheelchair, a computer, an electrical or electro-mechanicaldevice, or any combination thereof. Additionally, or in combination, thedevice can be a web browser and/or the device can be in communicationwith a web browser. For example, the device can be a processor incontrol of a web browser, the device can have a processor in control ofa web browser, the device can be in wired or wireless communication witha processor in control of a web browser, or any combination thereof.

Although not illustrated in FIG. 66, the algorithm 350 can record morethan two neural activities, for example, 3, 4, 5, 6, 7, 8, 9, 10, ormore neural activities in 3, 4, 5, 6, 7, 8, 9, 10, or more correspondingneural locations using the first and/or second sensors and/or by usingone or more other sensors (e.g., 3, 4, 5, 6, 7, 8, 9, 10, or more othersensors). The algorithm 350 can sense neural signals specific to one ormore devices for one or more of the parameters being controlled.

For example, the algorithm 350 can measure one or more third and fourthneural activities. In such a case, the algorithm 350 can prompt theprocessor to deliver one or more control signals to a device uponconfirming in the correlation analysis step 358 that one or more of thefourth measured neural activities are associated with at least onefirst, second, and/or third intent, upon confirming that multiple fourthneural activities are associated with one or more first, second, and/orthird intents, upon confirming that at least one of the one or morefourth neural activities is associated with multiple first, second,and/or third intents, upon confirming that an average of the fourthneural activities is associated with an average of the first, second,and/or third intents, or any combination thereof. The steps 354, 356,358 of the algorithm 350 can be repeated for each neural area beingrecorded until at least one control signal is delivered to the device.

FIG. 67 illustrates a variation of another algorithm 350 for processingneural signals from two or more neural areas that are received, forexample, from one or more stent devices 100. The algorithm 450 canprocess the received neural signals to determine whether the signalscorrespond to a user's intended action. Upon starting at block 452, thealgorithm 450 can record brain signals 454 from multiple neurallocations, predict the neural activity 456 of at least one of themeasured brain signals 454, and perform a correlation analysis 458between at least one of the measured activities and at least one of thepredicted activities. For example, FIG. 67 illustrates that thealgorithm 450 can record brain signals 454 from a first location 454 aand a second location 454 b. The neural activity in different areas canbe recorded simultaneously or sequentially relative to activity recordedin one or more other areas (e.g., the signals at the second location 454b can be recorded at the same time as the signals at the first location454 a or at a later time). The recorded signals 454 can be measured withone or more sensors on one or multiple implants, can be measured withthe same or different implants (e.g., first and second stent devices100), and can record signals in the brain and/or outside of the brain,for example, as described above with reference to algorithm 350.

Once the first and second signals 454 a, 454 b are received in step 454,the algorithm 450 can predict 456 the neural activity of one or more ofthe measured brain signals 454 (e.g., the first and/or second brainsignals 454 a, 454 b). In the prediction step 456, activity from one ofthe measured neural areas can be used to predict 456 the activity inanother neural area. Alternatively, or in combination, multiple measuredactivities of one of the neural areas can be used to predict 456 theactivity in another neural area. Alternatively, or in combination,measured activities from multiple neural areas can be used to predict456 the activity in one or multiple other neural areas. For example,FIG. 67 illustrates that the algorithm 450 can predict 456 the neuralactivity of the second location 456 b using the activity measured in thefirst neural area 454 a. Other information can also be used to predictneural activities, including neural data stored in the memory describedabove with reference to the algorithm 350.

Once the activity of one of the neural areas is predicted 456 based atleast partly on the activity measured 454 in another neural area and/oron stored neural data, the algorithm 450 can perform a correlationanalysis 458 to determine whether to actuate 460 or not actuate 462 adevice associated with or otherwise controllable by the algorithm 450.The correlation analysis 458 can ascertain error between one or more ofthe recorded activities 454 and one or more of the predicted activities456. For example, the correlation analysis 458 can calculate an errorbetween the measured first activity 454 a and a predicted first activity456 a and/or between the measured second activity 454 b and thepredicted second activity 456 b. The predicted first activity 456 a isnot shown in FIG. 67. This activity can be predicted based on themeasured second activity or on any other measured activity differentfrom the measured first activity. Similarly, the predicted secondactivity can be based on the measured first activity or on any othermeasured activity different from the measured second activity.

FIG. 67 illustrates that if the correlation analysis 458 determines thatthe predicted second activity 456 b is the same as or substantially thesame as (also referred to as associated with or substantially associatedwith) the measured second activity 454 b, a processor can be programmedto determine the intent 459 of the first and/or second measuredactivities 454 a, 454 b to determine the executed action of the device.The algorithm 450 can then generate one or more control signalsconfigured to actuate 460 the device, for example, in the decoding step459 or subsequent to the decoding step 459. Likewise, if the correlationanalysis 358 determines that the measured and predicted secondactivities 454 b, 456 b are not associated with one another, theprocessor can be programmed to not actuate 462 the device. Stateddifferently, if the algorithm 450 confirms that the measured andpredicted second activities 454 b, 456 b are associated with oneanother, one or more control signals can be generated and delivered tothe device to actuate 460 the device, after which the algorithm 450 canreturn to the recording step 454 or end 464. Likewise, if the algorithm450 is unable to confirm that the measured and predicted secondactivities are associated with one another (e.g., if an error isdetected between them), the algorithm 450 can proceed to the recordingstep 454 or end 464 without actuating 462 the device.

For example, the algorithm 450 can determine the intent 459 of themeasured activities 454 and/or deliver the one or more control signalsto the device upon determining that the calculated error is below apre-determined error, upon determining that the calculated error isbelow multiple pre-determined errors, upon determining that multiplecalculated errors are below the pre-determined error, upon determiningthat an average of multiple calculated errors is below thepre-determined error, upon determining that an average of multiplecalculated errors is below an average of multiple pre-determined errors,or any combination thereof. The predetermined error or errors can bedetermined, for example, using prediction class matching and/orinstrumented class matching as described above. Here, if the intendedclass (e.g., the first measured neural activity)=the predicted class(e.g., the predicted neural activity), then the processor can decode oneor more of the associated intents in step 459 as described above.

FIG. 67 illustrates that the processor can be configured to make a “Yes”and a “No” decision. A “Yes” signal can prompt the processor to decode459 the measured first and/or second activities 454 a, 454 b and thentransmit one or more control signals to the device to actuate 462 thedevice. A “No” signal can prompt the processor to return to step 454 ofthe algorithm 450. The steps 454, 456, 458 of the algorithm 450 can berepeated until at least one control signal is delivered to the device.The algorithm 450 can start 452 automatically when the stent devices 100are in communication with the devices being controlled, or can becontrolled by the user or another party such as a care provider. Thealgorithm 450 can be used to control one or more parameters of thedevice as described above with reference to algorithm 350. The devicecan be an exoskeleton, a prosthetic limb, a speller, a wheelchair, acomputer, an electrical or electro-mechanical device, or any combinationthereof.

Although not illustrated in FIG. 67, the algorithm 450 can record morethan two neural activities, for example, 3, 4, 5, 6, 7, 8, 9, 10, ormore neural activities in 3, 4, 5, 6, 7, 8, 9, 10, or more correspondingneural locations using the first and/or second sensors and/or by usingone or more other sensors (e.g., 3, 4, 5, 6, 7, 8, 9, 10, or more othersensors). The algorithm 450 can sense neural signals specific to one ormore devices and one or more of the parameters being controlled. Forexample, the algorithm 350 can measure one or more third and fourthneural activities, and determine one or more intents to control thedevice. The steps 454, 456, 458 of the algorithm 450 can be repeated foreach neural area being recorded until at least one control signal isdelivered to the device.

FIG. 68 illustrates a variation of an adaptive control algorithm 500that allows for dual control of a device via both the user and thedevice itself. The algorithm 500 can enable both machine learning andhuman learning to occur as opposed to just one or the other. Thealgorithm 500 can be used alone without another algorithm or withanother algorithm, for example, with algorithm 350, with algorithm 450,or any combination thereof. For example, the algorithm 500 can be asubroutine of the algorithms 350, 450.

As shown in FIG. 68, the algorithm 500 can start at block 502 and thenestablish 504 a computer control percentage and a user controlpercentage that can be subsequently increased and/or decreased, forexample, based on a determination of a user's competence or proficiencywith the device. When the algorithm 500 is initially started 502, thecomputer control percentage can be about 75% to about 100% (e.g., about95%) and the user control percentage can be about 0% to about 25% (e.g.,about 5%). The total percentage of both control percentages addedtogether can be about 100%. Where multiple devices are used or otherwisein neural communication with a user, a separate computer controlpercentage can be established 504 for each device. Additionally, or incombination, a single computer control percentage can be split amongmultiple devices and/or among multiple control sources associated with asingle device.

The algorithm 500 can be used to adjust the user's and computer'scontrol of one or more parameters of a device. For example, the controlof one or more kinematic parameters can be monitored and adjusted by thealgorithm 500, including the control of trajectory, speed, velocity,position, or changes thereof. After the control percentages are set atblock 504, a neural signal associated with a parameter can be recorded506 and an estimate of the parameter can be obtained 510. The estimate510 can be obtained from the device that the user is controlling ortrying to control, or can be obtained from another separate device. Theneural activity recorded 506 and the machine estimate 510 can be used todecode a user's intent 508.

Once the user's intent 508 is decoded, a filter (e.g., a Kalman filter)can be trained by executing the parameter 514 (e.g., movement)associated with the decoded neural activity 508. The filter can be usedto calculate an error 516, for example, an error estimate, by comparingthe executed parameter 514 with the decoded intent 508 (also referred toas the decoded parameter 508 or the intended parameter 508). Thecalculated error/error estimate 516 can be based at least partly on thedecoded and estimated parameters 508, 510. The calculated error cancorrespond to a calculated control correlation (also referred to as acalculated control proficiency) between the measured neural activity 506and the desired intended parameter 510. The algorithm 500 can performthe error calculation 516 to determine whether to adjust the user andcomputer control percentages.

FIG. 68 illustrates that if the error analysis 516 determines that theintended parameter 508 is the same as or substantially the same as theexecuted parameter 514, a processor can decrease the computer controlpercentage 518 and correspondingly increase the user control percentage.Likewise, if the error analysis 516 determines that the intended andexecuted parameters 508, 510 are not the same, the processor can beprogrammed to obtain new neural signals to retrain the user at block 520and/or increase the computer control percentage and correspondinglydecrease the user control percentage. The algorithm 500 can adjust auser control percentage and a computer control percentage upondetermining that the calculated control correlation is below or above apre-determined error. For example, a processor can increase the usercontrol percentage and decrease the computer control percentage upondetermining the calculated control correlation is below thepre-determined. decrease the user control percentage and increase thecomputer control percentage upon determining that the calculated controlcorrelation is above the pre-determined error or another pre-determinederror, vice versa, or any combination thereof. Alternatively, or incombination, the processor can be programmed to provide no adjustment tothe user and computer control percentages upon determining the controlcorrelation is above the pre-determined error, above anotherpre-determined error, below the pre-determined error below anotherpre-determined error, or any combination thereof. The predeterminederror or errors can be determined, for example, using prediction classmatching and/or instrumented class matching as described above.

The adaptive training paradigm 500 can gradually and/or rapidly adjustthe control percentages by training both the user and the computer. Forexample, the user and computer control percentages can be adjusted by aprocessor in percentage increments of about 1% to about 25%, forexample, 1% increments, 2% increments, 10% increments, 25% or moreincrements, or any combination thereof. The algorithm 500 canincrementally increase the user control percentage from an initialpercentage of about 0% to about 25% to a final percentage of about 75%to about 100%, with the computer control percentage beingcorrespondingly decreased from an initial percentage of about 75% toabout 100% to a final percentage of about 0% to about 25%. For example,the algorithm can start with about a 90% computer control percentage andabout a 10% user control percentage, and then can gradually and/orrapidly increase the user's control leading to about 90% or more usercontrol, for example, 100% user control. The algorithm 500 can beiterated from 1 time to 10,000 or more times for the adaptive trainingto transition from the initial control percentages to the final controlpercentages. At every change in the user control percentage, thealgorithm 500 can be programmed to correspondingly change itserror/error estimate calculations. The training can be tailored to eachindividual whereby the time between algorithm adaptation and useradaptation can be altered. For example, the time interval between useradaptation and algorithm can be varied based on individual subjectsperformance. As another example, the signals used for adaptation can bevaried. For example the ratio of incorrect predictions to accurateprediction by the algorithm can be varied to optimize accuracy of asubject's or user's control of the external device, or any device orplatform linked to the one or multiple implanted stentrodes.

The algorithms 350, 450, 500 in FIGS. 66-68 can each provide discreteand/or continuous control of the device. The adaptive algorithm 500 inFIG. 68 can enhance user and machine learning and plasticity using oneor more stent devices 100 as discussed above. Neural activities can berecorded and the associated intents decoded in algorithms 350, 450, 500,for example, as follows: (1) record the neural signal, filter at about 2Hz to about 200 Hz, and remove artifacts, (2) obtain features ofinterest, e.g., power in frequency bands 4 Hz to 12 Hz, 13 Hz to 28 Hz,29 Hz to 45 Hz, 55 Hz to 80 Hz, 81 Hz to 120 Hz, 121 Hz to 180 Hz, (3)apply a linear regression model to the results, for example,y(t)=X(t)×A+E(t), where A represents the linear parameters, E(t) is theerror term, X(t) is the feature vectors and y(t) is the desired output.

Dual Phased Multipolar Neural Stimulation

The methods, devices, and systems described herein can be capable ofproviding dual multipolar stimulation to neural tissue. In suchvariations, the two multipolar signals can be phased with one another toachieve dual phased multipolar stimulation. Dual phased multipolarstimulation can be provided in addition to traditional monopolar,traditional bipolar, and traditional multipolar stimulation. The use ofdual phased multipolar stimulation can allow neural tissue to be moreaccurately targeted, for example, by allowing the stimulation to befocused on one or more regions of neural tissue (e.g., one or moreregions in the brain) without affecting other adjacent regions. Thelocation, direction and depth of stimulation can be controlled with dualmultipolar stimulation by focusing one or more currents on a targetarea, summing one or more of the currents in the target area, and/oradjusting the amplitude of one or more currents. Traditional stimulationtechniques that do not allow for current summation. Dual multipolarstimulation can also reduce the stimulation current required to achievethe desired stimulation level by utilizing multiple current sourcesinstead of, for example, just one current source. The total currentdelivered can be divided among the multiple current sources such thatthe desired stimulation current is only achieved or is otherwise mostfocused in the target area. For example, instead of a single currentsource at full strength, two current sources can be used in a dualphased polar stimulation arrangement where each of the two currentsources has half the current strength (50% and 50%) as compared to thecurrent strength of the single current source. However, any percentagecurrent distribution among the two sources is appreciated, for example,10% and 90%, 20% and 80%, 30% and 70%, 40% and 60%. When the system hasmultiple current sources (e.g., 2 to 50 or more current sources), one ormore of the current sources can have a current strength that is lessthan the current strength of variations where current summation is notutilized. The current can be distributed among multiple current sourcesevenly or unevenly such that all the current sources deliver currenthaving the same current strength, or such that at least two currentsources deliver current having current strengths different from oneanother. The multiple current sources can be independent from oneanother and/or one or more of the current sources can be dependent onone or more other current sources. Dual phased multipolar currentdelivery can function similar to dual phased multipolar ultrasounddelivery.

To stimulate neural tissue, one or more stent devices 100 can beconfigured to deliver one or more currents to a target area by passingcurrent from one or more current sources to one or more current sinks.Each current source can be distributed among one or more electrodes 131of a stent device 100. The current from one or more of the one or morecurrent sources can be steered to or otherwise focused on one or more ofthe one or more current sinks such that the delivered currents passthrough one or multiple target areas. With dual phased multipolarstimulation, the currents in the target areas can sum to achieve thedesire stimulation level. For example, FIGS. 69A-69D illustrate aschematic variation of electrodes 131 of a stent device 100 deliveringtraditional monopolar stimulation 600 a in FIG. 69A, deliveringtraditional bipolar stimulation 600 b in FIG. 69B, deliveringtraditional multipolar stimulation 600 c in FIG. 69C, and deliveringdual multipolar stimulation 600 d in FIG. 69D. FIG. 69E illustrates aschematic variation of electrodes 131 a of a first stent device 100 aand electrodes 131 b of a second stent device 100 b delivering dualmultipolar stimulation 600 e. The patterns and polarity of thestimulations 600 a, 600 b, 600 c, 600 d, 600 e shown in FIGS. 69A-69Eare exemplary and illustrate the area of neural activation (alsoreferred to as the current spread). The patterns and polarities of astimulation can be static or dynamic such that the stimulation beingdelivered can be held constant or adjusted in real-time, for example,based on a user's responsiveness to the stimulation and/or based oncriteria unrelated to a user's responsiveness (e.g., predeterminedstimulation times, pre-determined stimulation sequences, pre-determinedstimulation strengths). Additionally, or in combination, the patternsand polarities can be pulsed or have another delivery protocol that isvariable in nature.

One or more currents can pass through one or multiple target areas andbe summed with one or more other currents in each target area that canlikewise pass through one or multiple target areas. For example, a firstcurrent and a second current can pass through and sum in a target areato a stimulation current. As another example, a first current can passthrough a first target area and a second target area, a second currentcan sum with the first current in the first target area but not in thesecond target area, and a third current can sum with the first currentin the second target area but not in the first target area. The firstand second currents can sum to a first stimulation current and the firstand third currents can sum to a second stimulation current equal to ordifferent from the first stimulation current.

As described above, the current from one or more of the one or morecurrent sources can be steered to one or more of the one or more currentsinks. Steering can include pulling the current from one or more of theone or more current sources with one or more of the one or more currentsinks, where each current sink can be configured to pull current fromone or more designated current sources. A designated current source is acurrent source that is configured to deliver current to one or morespecific current sinks. Steering can include pushing the current fromone or more of the one or more current sources to one or more of the oneor more current sinks, where each current source can be configured topush current to one or more designated current sinks. A designatedcurrent sink is a current sink that is configured to receive currentfrom one or more specific current sources. For example, a first currentcan be delivered to the target area by steering the first current from afirst current source to a first current sink or multiple first currentsinks.

At least two currents can be simultaneously delivered to a target areavia pulling or pushing. For example, two or more of the at least twocurrents can be steered to the target area such that at least twocurrents sum in the target area to a stimulation current having anenergy sufficient to stimulate neural tissue in the target area. Asanother example, a first current can be delivered to a target area bysteering the first current from a first current source to a firstcurrent sink and simultaneously delivering a second current to thetarget area by steering the second current from a second current sourceto a second current sink.

The one or more current sources can be independent from one another andthe one or more current sinks can be independent from one another.

The devices described herein can have any arrangement of currentsources, current sinks, and electrodes. For example, one or moreimplants (e.g., stent devices 100) can have one or more current sourcesand current sinks such that the current sources and current sinks areall on the same implant. In such variations, each implant can havemultiple electrodes (e.g., electrodes 131) where each current source canbe one or multiple current source electrodes and each current sink canbe one or multiple current sink electrodes. As another example, a firstimplant (e.g., first stent device 100 a) can have the one or morecurrent sources and a second implant (e.g., second stent device 100 b)can have one or more current sinks such that the one or more currentsources are on a different implant than the one or more current sinks.In such variations, the first implant can have one or multipleelectrodes and each current source can be one or multiple current sourceelectrodes. The second implant can likewise have one or multipleelectrodes and each current sink can be one or multiple current sinkelectrodes. As yet another example, a first implant (e.g., first stentdevice 100 a) can have at least one current source and at least onecurrent sink and a second implant (e.g., second stent device 100 b) canhave at least one current source and at least one current sink such thateach of the first and second implants have one or more current sourcesand one or more current sinks. In such variations, the first and secondimplants can each have electrodes where each current source can be oneor multiple current source electrodes and where each current sink can beone or multiple current sink electrodes.

The devices described herein can selectively target, simultaneously orsequentially, one or more target areas by selectively activating one ormore of the one or more current sources and/or by selectively activatingone or more of the one or more current sinks. For example, the devicesdescribed herein can selectively target, simultaneously or sequentially,one or more target areas by selectively activating one or more of theone or more current source electrodes and/or by selectively activatingone or more of the one or more current sink electrodes.

When delivering dual phased multipolar stimulation, for example, a firstcurrent source can be in a first location and a first current sink canbe in a second location. The first location can correspond to a vesselfirst location and the second location can correspond to a vessel secondlocation. The vessel first location can be in a first vessel and thevessel second location can be in a second vessel different from thefirst vessel. The vessel first and second locations can be on oppositesides of a plane that passes through the target area.

As another example, a first current source can be in a first location, asecond current source can be in a second location and a first currentsink can be in a third location. The first location can correspond to avessel first location, the second location can correspond to a vesselsecond location and the third location can correspond to a vessel thirdlocation. The vessel first, second and/or third locations can be in thesame or different vessels from one another. The vessel first and/orsecond locations and the vessel third location can be on opposite sidesof a plane that passes through the target area.

As yet another example, a first current source can be in a firstlocation, a second current source can be in a second location, a firstcurrent sink can be in a third location and a second current sink can bein a fourth location. The first location can correspond to a vesselfirst location, the second location can correspond to a vessel secondlocation, the third location can correspond to a vessel third location,and the fourth location can correspond to a vessel fourth location. Thevessel first, second, third and/or fourth locations can be in the sameor different vessels from one another. The vessel first and/or secondlocations and the vessel third and/or fourth locations can be onopposite sides of a plane that passes through the target area. Thevessel first and third locations can be on opposite sides of a firstplane that passes through the target area and the vessel second andfourth locations can be on opposite sides of a second plane that passesthrough the target area.

The devices described herein can be configured to limit a first currentto limit a stimulation depth of a first implant and to limit a secondcurrent to limit a stimulation depth of a second implant.

As described above, the devices described herein can adjust a strengthof at least one of the one or more current sources to adjust astimulation strength and/or a stimulation depth. Such adjustments can beaccomplished by increasing and/or decreasing the amperage of at leastone of the one or more current sources and/or by increasing and/ordecreasing the number of currents that sum in the target area.

Similarly described above, one or more currents can be sequentiallyand/or simultaneously delivered to one or multiple target areas bypassing current from one or multiple current sources to one or multiplecurrent sinks.

Dual phase multipolar stimulation can be used to target neural tissueanywhere in the body, for example, in and/or outside of the brainincluding, for example, the cortex, the subcortex, the cerebellum, thethalamus, the brain stem, the spinal cord, organs (e.g., heart, lungs,stomach, kidneys and pancreas), muscles, or any combination thereof. Thecortical and subcortical locations can include, for example, the primarymotor cortex (M1), the supplementary motor area (SMA), the posteriorparietal cortex (PPC), the primary somatosensory cortex (51), thecerebellum, the thalamus and the brain stem.

Although the foregoing description refers to dual phased multipolarstimulation throughout, any single stent and/or multi-stent n-phasedmultipolar stimulation can be provided, for example, with one ormultiple implants. In addition to dual phase multipolar stimulation,3-phase, 4-phase, 5-phase, 6-phase, or n+1 phase multipolar stimulationcan be delivered to one or more neural target areas. Alternatively, orin combination, the devices described herein can be configured todeliver two or more dual phased multipolar stimulations to one ormultiple target areas. For example, FIGS. 70A-70H illustrate schematicvariations of stent devices 100 implanted in the brain in variouslocations delivering various types of stimulation. FIGS. 70A-70Hillustrate various MRI images with stent devices 100 delivering neuralstimulation.

FIG. 70A illustrates a stent device 100 located in the superior sagittalsinus delivering monopolar stimulation 700 a. External returnstimulation is also shown.

FIG. 70B illustrates a stent device 100 located in the superior sagittalsinus delivering bipolar stimulation 700 b.

FIG. 70C illustrates a dual stent implementation delivering multipolarstimulation 700 c. A first stent device (e.g., a first stent 100 a) isshown located in the superior sagittal sinus and a second stent device(e.g., a second stent 100 b) is shown located in the inferior sagittalsinus.

FIG. 70D illustrates a dual stent implementation delivering dualmultipolar stimulation 700 d. A first stent device (e.g., a first stent100 a) is shown located in the transverse sinus delivering stimulation700 d-1 and a second stent device (e.g., a second stent 100 b) is shownlocated in the pericallosal artery delivering stimulation 700 d-2. Thefirst and second stimulations 700 d-1, 700 d-2 can sum where the twostimulations overlap in region 700 d-3. Neural tissue can be stimulatedin region 700 d-1, region 700 d-2, and/or region 700 d-3. For example,neural tissue can be stimulated in region 700 d-1 but not in the portionof regions 700 d-1 and 700 d-2 that do not overlap with each other inregion 700 d-3. As another example, neural tissue can be stimulated inregion 700 d-1 at a first stimulation magnitude, in region 700 d-2 at asecond stimulation magnitude, and in region 700 d-3 at a thirdstimulation magnitude. The first and second stimulation magnitudes canbe the same or different from one another. The third stimulationmagnitude can be the sum of the first and second stimulation magnitudesthat are in the overlap region 700 d-3. The strength of the stimulationdelivered by the first and second stents (e.g., 100 a, 100 b) can decayas the distance from each respective stent increases, for example, as aresult of energy being absorbed by tissue. The stimulation delivered cantherefore naturally vary within each stimulation region 700 d-1, 700d-2, 700 d-3. The stimulation in region 700 d-3 can be heldsubstantially constant or can be varied.

FIG. 70E illustrates a dual stent implementation delivering monopolarstimulation 700 e. A first stent device (e.g., a first stent 100 a) isshown located in the superior sagittal sinus and a second stent device(e.g., a second stent 100 b) is shown located in the inferior sagittalsinus.

FIG. 70F illustrates a dual stent implementation delivering monomultipolar stimulation 700 f. A first stent device (e.g., a first stent100 a) is shown located in the superior sagittal sinus and a secondstent device (e.g., a second stent 100 b) is shown located in theinferior sagittal sinus.

FIG. 70G illustrates a dual stent implementation delivering dualmultipolar stimulation 700 g. A first stent device (e.g., a first stent100 a) is shown located in the superior sagittal sinus deliveringstimulation 700 g-1 and a second stent device (e.g., a second stent 100b) is shown located in the inferior sagittal sinus deliveringstimulation 700 g-2.

FIG. 70H illustrates a dual stent implementation delivering dualmultipolar stimulation 700 h. A first stent device (e.g., a first stent100 a) is shown located in the inferior sagittal sinus deliveringstimulation 700 h-1 and a second stent device (e.g., a second stent 100b) is shown located in the internal carotid artery deliveringstimulation 700 h-2.

FIG. 701(a) illustrates a first stent device 100 a in a first vessel 800a having a first vessel wall 800 aw and a second stent device 100 b in asecond vessel 800 b having a second vessel wall 800 bw, where the firstand second stents 100 a, 100 b are configured to deliver signals (e.g.,stimulation signals) to a target location 802. For example, the firststent 100 a can deliver a first stent signal 700 i-1 and the secondstent 100 b can deliver a second stent signal 700 i-2 to the targetlocation 802. The signals can be, for example, electrical impulses,ultrasound signals, or both, including any other type of tissuestimulating signals. The signals 700 i-1 and 700 i-2 can sum in a signalregion 804. The summed signals in the signal region 804 can stimulatetissue. The signal region 804 can be a tissue activation area. Thesignal region 804 can be a tissue activatable area. Tissue in theactivatable area 804 can be activated, for example, when the devices(e.g., 100 a, 100 b) deliver or emit a signal or signals toward thetarget area 802. When the two signals (e.g., 700 i-1, 700 i-2) addtogether tissue can be activated, for example, in the signal region 804.The summed signal in the signal region 804 can be equal to or greaterthan a neural tissue activation threshold required to activate neuronsand/or neuron bundles in the target area 802. The signal region 804 canbe in, can overlap with, or can coincide with some or all of the tissuein the desired target area 802. As another example, the signal region804 can be in, can overlap with, or can coincide with some or all of thetissue in an undesired or suboptimal target area 802, for example, whereanatomical constraints, medical conditions (e.g., aneurysms), surgicalcomplications, or other mitigating factors can result in placement ofthe stent or stents (e.g., devices 100 a, 100 b) in the vessel orvessels in secondary, tertiary or unplanned locations.

Neural tissue inside and/or outside the signal region 804 can bestimulated by the first stent first signal 700 i-1, by the second stentsignal 700 i-2, by the combination of the first and second signals 700i-1 and 700 i-2, or by any combination thereof. For example, FIG. 701(a)illustrates that the first and second signals can sum in the signalregion 804 to stimulate neural tissue in the target area 802 but thatneural tissue outside of region 804 may (e.g., in a device and/or systemfirst variation, for example, the variation shown in FIG. 701(a)) or maynot (e.g., in the device and/or system first variation and/or in adevice and/or system second variation) be stimulated by the first andsecond stents 100 a, 100 b outside the signal region 804. As a firstexample, FIG. 701(a) illustrates that the first and second signals cansum in the signal region 804 to stimulate neural tissue in the targetarea 802 but that neural tissue outside of the signal region 804 is notstimulated by the first and second stents 100 a, 100 b. As a secondexample, FIG. 701 illustrates that neural tissue in and outside thesignal region 804 can be stimulated by the first and second stents 100a, 100 b, whereby the neural tissue outside of the signal summationregion 804 can be, for example, stimulated to a lesser extent than thetissue inside the signal region 804. As a third example, multiplebell-shaped signals or signal spikes (e.g., signals 700 i-1 and 700 i-2)can be delivered from the stents (e.g., 100 a, 100 b) to control theshape of the signal summation region 804, to create multiple signalsummation regions 804 (e.g., 2 to 50, 2 to 100, 2 to 1000, includingevery 1 region increment within these ranges), or both, to achieve thedesired shape and/or number of stimulation regions 804.

The first and second devices 100 a, 100 b can have any of the featuresdisclosed, contemplated and/or illustrated herein. The first and secondvessels 800 a, 800 b can be the same or a different vessel and can beany blood vessel in the body. The target location 802 can be any tissuelocation disclosed, contemplated and/or illustrated herein. The devices100 a and 100 b can emit signals away from the devices 100 a and 100 b,respectively, for example, to stimulate tissue (e.g., tissue in thetarget area 802), the devices 100 a and 100 b can record signalsreceived from the tissue (e.g., tissue in the target area 802), or both(e.g., the devices 100 a and/or 100 b can stimulate tissue and/or canrecord signals from tissue).

The devices 100 (e.g., devices 100 a, 100 b) can emit signals away fromitself, toward itself, or both. The device 100 a can emit signals towarditself, for example, where the devices (e.g., 100 a, 100 b) have alongitudinal curvature such that one or more portions of the device 100can be oriented or directed to face back onto itself. A longitudinalaxis of the device 100 a can be straight, curved, or both. The device100 a can emit signals toward itself, for example, where the device 100a has a longitudinal curvature such that one or more first portions ofthe device 100 (e.g., struts, electrodes) are oriented or directed toface back onto one or more second portions of the device 100 (e.g.,struts, electrodes). The energy emitters of the device 100 (e.g., theelectrodes of the device 100) can emit energy at any angle away from thedevice longitudinal axis, where the device longitudinal axis can be, forexample, a center axis through the blood flow channel defined by thedevice, or as another example, a center axis through one or more of thestruts. The energy emitters (e.g., electordes) can emit energy along anemission axis that extends away from or toward the device longitudinalaxis at an emission angle of, for example, about 1 degree to about 360degrees, including every 1 degree increment within this range (e.g., 15degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees,120 degrees, 135 degrees, 150 degrees, 165 degrees). The emission axiscan intersect with or not intersect with the device longitudinal axis.Although two devices 100 a and 100 b and two vessels 800 a and 800 b areshown in FIG. 70I(a), the device 100 b can be a second portion of thedevice 100 a in the vessel 800 a such that the device 100 b in FIG.70I(a) is another part of the device 100 a and such that the bloodvessel 800 b is another portion of the blood vessel 800 a, for example,where device 100 a is curved in the vessel 800 a. In such cases, thedevice first portion 100 a can be a first longitudinal end of the deviceor any segment of the device 100 a between the first longitudinalterminal end of the device and the second longitudinal terminal end ofthe device. The device second portion (illustrated as 100 b in thisportion of the detailed description) can be a second longitudinal end ofthe device or any segment of the device 100 a between the firstlongitudinal terminal end of the device and the second longitudinalterminal end of the device.

FIG. 70I(a) further illustrates that some or all of the signal summationregion 804 can overlap with the target area 802. For example, FIG.70I(a) illustrates that the signal region 804 can have a signal regionfirst region 804 a, a signal region second region 804 b and a signalregion third region 804 c, where the region 804 a is inside the targetarea 802 and the regions 804 b and 804 c are outside of the target area802.

FIG. 70I(b) illustrates that all of the target area 802 can be withinthe signal summation region 804.

FIG. 70I(c) illustrates that the target area 802 can have the same exactshape and size as the signal summation region 804. The stent or stents(e.g., 100 a and 100 b) can be controlled to emit signals which sum toapproximate the desired shape, size, and number of target areas 802.

FIG. 70I(d) illustrates that the one or multiple devices (e.g.,stentrodes 100 a, 100 b) can emit multiple bell-shaped signals, signalspikes, signals, or any combination thereof (e.g., signals 700 i-1 and700 i-2) having different strengths. Multiple signals can be deliveredfrom the stents (e.g., 100 a, 100 b), for example, to control the sizeand/or shape of the signal summation region 804, to create multiplesignal summation regions 804 (e.g., 2 to 50, 2 to 100, 2 to 1000,including every 1 region increment within these ranges), or both, toadvantageously achieve the desired size, shape, and/or number ofstimulation regions 804. For example, FIG. 70I(d) illustrates that thefirst stent 100 a can deliver a first stent first signal 700 i-1 a and afirst stent second signal 700 i-1 b to the target location 802 and thatthe second stent 100 b can deliver a second stent first signal 700 i-2 aand a second stent second signal 700 i-2 b to the target location 802.The signals 700 i-1 a and 700 i-2 a can sum in a first signal region804-1. The signals 700 i-1 b and 700 i-2 b can sum in a second signalregion 804-2. The first signal region 804-1 can be the same or differentsize and shape than the second signal region 804-2. The first and secondsignal regions 804-1, 804-2 can stimulate the same tissue or differenttissues (e.g., the same brain regions or different brain regions). Thesummed signals in the signal regions 804-1 and 804-2 can stimulatetissue in these respective regions.

FIG. 70I(e) illustrates that the signal first and second regions 804-1,804-2 can be different sizes. For example, the second signal region804-2 is shown larger than the first signal region 804-1.

FIG. 70I(f) illustrates that the one or multiple devices (e.g.,stentrodes 100 a, 100 b) can stimulate multiple target areas 802 (e.g.,2 to 10 target areas, 2 to 100 target areas, 2 to 1000 target areas,including every 1 target area increment within these ranges, forexample, a first target). For example, the first and second devices 100a, 100 b can stimulate a first target area 802-1 and the first andsecond devices 100 a, 100 b can stimulate a second target area 802-2.For example, the first and second devices 100 a, 100 b can sum in afirst activation region 804-1 and in a second activation region 804-2.

FIG. 70(g) illustrates that the stimulation system can include three ormore stentrode devices, for example, stent 100 a, 100 b and 100 c, wherea signal from the first stent 100 a can sum with the signals from thesecond stent 100 b and/or from the third stent 100 c, where a signalfrom the second stent 100 b can sum with the signals from the firststent 100 a and/or from the third stent 100 c, and where a signal fromthe third stent 100 c can sum with the signals from the first stent 100a and/or from the second stent 100 b. For example, FIG. 70I(g)illustrates that the first stent first signal 700 i-1 a can sum with thesecond stent signal 700 i-2 and that the first stent second signal 700i-1 b can sum with a third stent signal 700 i-3.

Although two devices 100 a and 100 b and two vessels 800 a and 800 b areshown in FIGS. 70I(a)-70(g), the device 100 b can be a second portion ofthe device 100 a in the vessel 800 a such that the device 100 b in thesefigures is another part of the device 100 a and such that the bloodvessel 800 b is another portion of the blood vessel 800 a, for example,where device 100 a is curved in the vessel 800 a. In such cases, thedevice first portion 100 a can be a first longitudinal end of the deviceor any segment of the device 100 a between the first longitudinalterminal end of the device and the second longitudinal terminal end ofthe device. The device second portion (illustrated as 100 b in thisportion of the detailed description) can be a second longitudinal end ofthe device or any segment of the device 100 a between the firstlongitudinal terminal end of the device and the second longitudinalterminal end of the device.

Each stent device in FIGS. 70A-70H is shown schematically as four dots,with the exception of FIG. 70D in which the illustrated stent devicesare each shown schematically as three dots. The various stimulationpatterns 700 a-700 h shown in FIGS. 70A-70I(g) are exemplary andillustrate the area of neural activation (also referred to as thecurrent spread). The stimulation patterns 700 a-700 h illustrated by theshaded regions in FIGS. 70A-70H are exemplary cross-sectional schematicvariations of a portion of the three-dimensional current spread beingdelivered by the illustrated stent devices 100. The stimulation patternsin FIGS. 70I(a)-(g) are likewise exemplary. FIGS. 70A-70H illustratethat one or multiple neural areas can be targeted simultaneously. Asdescribed above, the patterns and polarities of a stimulation can bestatic or dynamic such that the stimulation being delivered can be heldconstant or adjusted in real-time, for example, based on a user'sresponsiveness to the stimulation and/or based on criteria unrelated toa user's responsiveness (e.g., predetermined stimulation times,pre-determined stimulation sequences, pre-determined stimulationstrengths). Additionally, or in combination, the patterns and polaritiescan be pulsed or have another delivery protocol that is variable innature. The energy emitted from a first device in these figures can sumwith energy emitted from a second device to activate tissue (e.g., inany of the configurations shown in FIGS. 70A-70H). As another example,the energy emitted from the devices shown in FIGS. 70A-70H can activatetissue with or without the emitted energy from the different energysources (e.g., devices 100) summing together, for example, from multipledevices 100 (e.g., a first device, a second device, a third device, ormore devices, or any combination thereof). For example, where there aremultiple summation regions 804, these multiple regions can be stimulatedindependently from one another, sequentially, simultaneously, or anycombination thereof, for example, over an energy delivery period.

FIG. 71A illustrates an exemplary heat map 805 a when the device ordevices (e.g., 100 a, 100 b) stimulate tissue with monopolarstimulation, where the heat map 805 a shows large current spreads (e.g.,the darker areas).

FIG. 71B illustrates an exemplary heat map 805 b when the device ordevices (e.g., 100 a, 100 b) stimulate tissue with dual multipolarstimulation, where the heat map 805 b shows focal current distributions,for example, showing a focused current distribution 806. Focused currentdistributions can advantageously allow more focused treatment ofsubjects and give more granularity to subjects in regards to control andaccuracy, for example, when compared to the monopolar stimulation heatmap 805 a of FIG. 71A. The focused current distributions that the deviceor devices (e.g., 100 a, 100 b) can provide can advantageously givesubjects more control and/or more accurate control of the externaldevices or systems linked to their one or more stentrodes (e.g., 100 a,100 b).

The heat maps 805 a and 805 b can be the heat maps in the target area802. The heat maps 805 a and 805 b can be the heat maps in the signalsummation regions 804. The heat maps 805 a and 805 b can be the heatmaps that span the target area 802 inside and outside of the signalsummation regions 804.

Power Generation

The devices described herein (e.g., the stent devices 100) can bepowered with blood flow, thermoelectricity, electromagnetism,piezoelectricity, or any combination thereof.

Many modifications will be apparent to those skilled in the art withoutdeparting from the scope of the present invention.

The reference to any prior art in this specification is not, and shouldnot be taken as, an acknowledgment or any form of suggestion that theprior art forms part of the common general knowledge in Australia

In this specification and the claims that follow, unless statedotherwise, the word “comprise” and its variations, such as “comprises”and “comprising”, imply the inclusion of a stated integer, step, orgroup of integers or steps, but not the exclusion of any other integeror step or group of integers or steps.

References in this specification to any prior publication, informationderived from any said prior publication, or any known matter are not andshould not be taken as an acknowledgement, admission or suggestion thatsaid prior publication, or any information derived from this priorpublication or known matter forms part of the common general knowledgein the field of endeavor to which the specification relates.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Like referencenumerals in the drawings indicate identical or functionally similarfeatures/elements. Any species element of a genus element can have thecharacteristics or elements of any other species element of that genus.Some elements may be absent from individual figures for reasons ofillustrative clarity. The above-described configurations, elements orcomplete assemblies and methods and their elements for carrying out thedisclosure, and variations of aspects of the disclosure can be combinedand modified with each other in any combination. All dimensions shown inthe drawings are exemplary.

1. A method of controlling an apparatus in communication with a brainmachine interface, the method comprising: measuring a first neuralactivity associated with a first intent to control the apparatus, wheremeasuring the first neural activity comprises using a first sensor;measuring a second neural activity using a second sensor; and deliveringone or more first control signals to the apparatus upon confirming thatthe second neural activity is associated with the first intent.
 2. Themethod of claim 1, further comprising: decoding the first intent fromthe measured first neural activity; and decoding a second intent fromthe measured second neural activity, where the delivering step comprisesdelivering the one or more first control signals to the apparatus uponconfirming that the second intent is associated with the first intent.3. The method of claim 2, where decoding the first and second intentscomprises referencing previously measured neural activities stored in amemory.
 4. The method of claim 1, further comprising repeating themeasuring steps until at least one first control signal is delivered tothe apparatus.
 5. The method of claim 1, where the delivering stepcomprises delivering one or multiple first control signals to control afirst parameter and/or a second parameter of the apparatus.
 6. Themethod of claim 1, where the first sensor is proximate or in a firstneural area and where the second sensor is proximate or in a secondneural area.
 7. The method of claim 6, wherein the first and secondneural areas are in the brain.
 8. The method of claim 1, furthercomprising: determining a desired parameter of the apparatus;calculating a control correlation between the measured first neuralactivity and the desired parameter; and adjusting a user controlpercentage and a computer control percentage of the apparatus upondetermining the control correlation is below a pre-determined error. 9.The method of claim 8, where the adjusting step comprises increasing theuser control percentage and decreasing the computer control percentageupon determining the control correlation is below the pre-determinederror and/or where the adjusting step comprises decreasing the usercontrol percentage and increasing the computer control percentage upondetermining the control correlation is above the pre-determined error.10. The method of claim 9, where the user control percentage isinitially 0% to 25% and the computer control percentage is initially 75%to 100%, further comprising incrementally increasing the user controlpercentage from an initial percentage of 0% to 25% to a final percentageof 75% to 100%. 11.-30. (canceled)